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VA to Reexamine 24,000 Veterans for TBI

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Conflicting and confusing guidance documents may have led to missed cases of traumatic brain injuries.

More than 24,000 veterans who received examinations but were not diagnosed with traumatic brain injuries (TBIs) will be eligible for new medical examinations, the VA has announced. Due to confusing guidance documents, the original examinations were not conducted by a psychiatrist, physiatrist, neurosurgeon, or neurologist as mandated by VA policy. The 24,000 veterans may be eligible for additional benefits and service-connected compensation based on the results of the new examinations.

“Traumatic Brain Injury is a signature injury in veterans returning from the conflicts in Iraq and Afghanistan, and VA is proud to be an organization that sets the bar high for supporting these, and all, veterans,” said Secretary of Veterans Affairs Robert McDonald in a statement. “Providing support for veterans suffering from a TBI is a priority and a privilege, and we must make certain they receive a just and fair rating for their disabilities.”

The current VA policy dates to 2007 and requires that a specialist complete a TBI examination when VA does not have a prior diagnosis. However, given the rapidly changing science around TBI since 2007, the VA has issued multiple additional guidance documents. These additional guidance documents, the VA notes, “created confusion regarding the policy.” 

“We let these veterans down,” Secretary McDonald said. “That is why we are taking every step necessary to grant equitable relief to those affected to ensure they receive the full benefits to which they are entitled.”

Veterans will not be required to submit new claims and the VA has pledged to contact the identified patients to offer them a new examination. According to the VA > 13,000 veterans are already receiving 10% or higher service-connected compensation benefits for TBI.

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Conflicting and confusing guidance documents may have led to missed cases of traumatic brain injuries.
Conflicting and confusing guidance documents may have led to missed cases of traumatic brain injuries.

More than 24,000 veterans who received examinations but were not diagnosed with traumatic brain injuries (TBIs) will be eligible for new medical examinations, the VA has announced. Due to confusing guidance documents, the original examinations were not conducted by a psychiatrist, physiatrist, neurosurgeon, or neurologist as mandated by VA policy. The 24,000 veterans may be eligible for additional benefits and service-connected compensation based on the results of the new examinations.

“Traumatic Brain Injury is a signature injury in veterans returning from the conflicts in Iraq and Afghanistan, and VA is proud to be an organization that sets the bar high for supporting these, and all, veterans,” said Secretary of Veterans Affairs Robert McDonald in a statement. “Providing support for veterans suffering from a TBI is a priority and a privilege, and we must make certain they receive a just and fair rating for their disabilities.”

The current VA policy dates to 2007 and requires that a specialist complete a TBI examination when VA does not have a prior diagnosis. However, given the rapidly changing science around TBI since 2007, the VA has issued multiple additional guidance documents. These additional guidance documents, the VA notes, “created confusion regarding the policy.” 

“We let these veterans down,” Secretary McDonald said. “That is why we are taking every step necessary to grant equitable relief to those affected to ensure they receive the full benefits to which they are entitled.”

Veterans will not be required to submit new claims and the VA has pledged to contact the identified patients to offer them a new examination. According to the VA > 13,000 veterans are already receiving 10% or higher service-connected compensation benefits for TBI.

More than 24,000 veterans who received examinations but were not diagnosed with traumatic brain injuries (TBIs) will be eligible for new medical examinations, the VA has announced. Due to confusing guidance documents, the original examinations were not conducted by a psychiatrist, physiatrist, neurosurgeon, or neurologist as mandated by VA policy. The 24,000 veterans may be eligible for additional benefits and service-connected compensation based on the results of the new examinations.

“Traumatic Brain Injury is a signature injury in veterans returning from the conflicts in Iraq and Afghanistan, and VA is proud to be an organization that sets the bar high for supporting these, and all, veterans,” said Secretary of Veterans Affairs Robert McDonald in a statement. “Providing support for veterans suffering from a TBI is a priority and a privilege, and we must make certain they receive a just and fair rating for their disabilities.”

The current VA policy dates to 2007 and requires that a specialist complete a TBI examination when VA does not have a prior diagnosis. However, given the rapidly changing science around TBI since 2007, the VA has issued multiple additional guidance documents. These additional guidance documents, the VA notes, “created confusion regarding the policy.” 

“We let these veterans down,” Secretary McDonald said. “That is why we are taking every step necessary to grant equitable relief to those affected to ensure they receive the full benefits to which they are entitled.”

Veterans will not be required to submit new claims and the VA has pledged to contact the identified patients to offer them a new examination. According to the VA > 13,000 veterans are already receiving 10% or higher service-connected compensation benefits for TBI.

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Conference News Update—American Association of Neurological Surgeons

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Stem Cell Transplantation Is Safe in Hemorrhagic Stroke

Intraventricular transplantation using bone marrow mesenchymal stem cells is safe in patients with hemorrhagic stroke, according to research presented by Asra Al Fauzi, MD, a neurosurgeon at Soetomo General Hospital in Surabaya, Indonesia.

This study examined a group of eight patients with supratentorial hemorrhagic stroke. All patients had received six months of treatment and had stable neurologic deficits and NIH Stroke Scale (NIHSS) scores of five to 25. Clinical outcomes were measured using the NIHSS scale six months after transplantation. Bone marrow was aspirated and taken from the patient to whom it was to be administered under aseptic conditions. Expansion of mesenchymal stem cells took three to four weeks. All patients were administered a mean of 20 × 106 cells intraventricularly.

Results showed improvement of the NIHSS score in five patients after treatment; three patients had no change in status. No important adverse events associated with transplant or surgery were observed during a six-month follow up. The study demonstrates that bone marrow mesenchymal stem cell can be transplanted intraventricularly with excellent tolerance and without complications, said Dr. Al Fauzi. Stem cell transplantation aiming to restore function in stroke is safe and feasible. Further randomized controlled trials are needed to evaluate its efficacy.

How Does Surgery for Cerebral Arteriovenous Malformation Affect Pulsatility and Resistance?

Embolization reduces flow in cerebral arteriovenous malformations (AVMs) before surgical resection, but changes in pulsatility index (PI) and resistance index (RI) are unknown. Sophia F. Shakur, MD, a neurosurgery resident at the University of Chicago Medical Center, and colleagues measured PI and RI in AVM arterial feeders before and after embolization or surgery.

The researchers reviewed the records of patients who underwent AVM embolization and surgical resection at a single institution between 2007 and 2014.Patients who had PI, RI, and flows obtained using quantitative magnetic resonance angiography were retrospectively reviewed. Hemodynamic parameters were compared between the feeder and contralateral artery before and after embolization or surgery.

Thirty-two patients with 48 feeder arteries underwent embolization (mean 1.3 sessions). Another 32 patients with 49 feeder arteries had surgery with or without preoperative embolization. Before treatment, flow volume rate and mean, systolic and diastolic flow velocities were significantly higher in feeders versus contralateral counterparts. PI and RI were significantly lower in feeder vessels, compared with contralateral vessels. After embolization, mean, systolic, and diastolic flow velocities increased significantly, but PI and RI did not change significantly. However, after surgery, mean, systolic, and diastolic flow velocities within feeders decreased significantly, and PI and RI normalized to match the indices of their contralateral counterparts.

Following partial AVM embolization, PI and RI were unchanged, and flow velocities in feeder arteries increased significantly, likely due to redistribution of flow through residual nidus. Complete surgical resection resulted in normalization of PI and RI and a concomitant decrease in flow velocities.

Temporal Evolution of ICP and PRx May Have Prognostic Significance

Studies of large cohorts of patients with traumatic brain injury (TBI) have shown that intracranial pressure (ICP) and the pressure reactivity index (PRx) are independently associated with patient outcome. How these parameters evolve over the course of the stay in an intensive care unit, and the question of whether this evolution has any prognostic importance, has not been well studied, however.

Hadie Adams, MD, a postdoctoral fellow at Johns Hopkins School of Medicine in Baltimore, and colleagues monitored ICP and PRx in 573 patients with severe TBI in a regional neurocritical care unit. Data were calculated in 12-hour epochs for the first 168 hours (ie, seven days) after the time of incident. Data were stratified by the presence of diffuse TBI (dTBI) or space occupying lesions (SOL), as well as by fatal or nonfatal outcome at six months post injury. Mixed linear modeling was used to assess change of ICP and PRx over time to detect differences in mortality.

Mean ICP peaked at between 24 hours and 36 hours after injury, but only in patients who died. The difference in mean ICP between patients with fatal and nonfatal outcome was significant for the first 120 hours after ictus. For PRx, patients with a fatal outcome also had higher (ie, more impaired) PRx throughout the first 168 hours after ictus. The separation of ICP and PRx was greatest in the first 72 hours after ictus. Also, mean differences of ICP and PRx between the outcome groups were more pronounced in patients with dTBI than those with SOL.

In this cohort of 573 patients with TBI and high-resolution physiologic data, ICP and PRx displayed a distinctive temporal evolution. Importantly, early ICP and PRx allowed for the clearest prognostic delineation, said Dr. Adams.

 

 

The optimal thresholds, prognostic significance, and clinical correlations of ICP and PRx are likely to be time-dependent, he added.

How Common Is Position-Related Neuropraxia In Spine Surgery?

Gurpreet Surinder Gandhoke, MD, a neurosurgeon in Pittsburgh, and colleagues examined the incidence of position-related neuropraxia in 4,489 consecutive patients undergoing spine surgery at a university hospital. Some patients in the group had peripheral nerve injury from positioning. The authors observed intraoperative monitoring (IOM) changes related to arm and leg positioning and calculated their sensitivity and specificity in predicting the development of a new position-related peripheral nerve injury. Impact of length of surgery and other variables, including age, sex, BMI, diabetes, hypertension, coronary artery disease, cardiovascular disease, and a history of smoking on the development of a new peripheral nerve injury were defined.

Patients were in the following positions: arms abducted and flexed at the elbow (64.7%), arms tucked at the side (35%), and the lateral position (0.3%). Thirteen of 4,489 patients developed a new positioning-related peripheral nerve deficit, 54% developed meralgia paresthetica, and 46% developed ulnar neuropathy.

Seventy-two patients (1.6%) developed IOM changes from positioning, and all of these patients underwent a repositioning maneuver. One of these 72 patients (1.3%) developed a new position-related nerve deficit. Of the 98.4% of patients who did not develop position-related IOM changes, 0.3% developed a new position-related nerve deficit.

Sensitivity of IOM to detect a new position-related nerve deficit was 7.69%, and the specificity was 98.41%. Neither length of surgery nor any analyzed patient-related variable significantly affected the development of a new neuropraxia. The incidence of a new position-related nerve deficit in spine surgery was less than 0.3%. IOM had high specificity and low sensitivity in detecting a positioning-related deficit.

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Stem Cell Transplantation Is Safe in Hemorrhagic Stroke

Intraventricular transplantation using bone marrow mesenchymal stem cells is safe in patients with hemorrhagic stroke, according to research presented by Asra Al Fauzi, MD, a neurosurgeon at Soetomo General Hospital in Surabaya, Indonesia.

This study examined a group of eight patients with supratentorial hemorrhagic stroke. All patients had received six months of treatment and had stable neurologic deficits and NIH Stroke Scale (NIHSS) scores of five to 25. Clinical outcomes were measured using the NIHSS scale six months after transplantation. Bone marrow was aspirated and taken from the patient to whom it was to be administered under aseptic conditions. Expansion of mesenchymal stem cells took three to four weeks. All patients were administered a mean of 20 × 106 cells intraventricularly.

Results showed improvement of the NIHSS score in five patients after treatment; three patients had no change in status. No important adverse events associated with transplant or surgery were observed during a six-month follow up. The study demonstrates that bone marrow mesenchymal stem cell can be transplanted intraventricularly with excellent tolerance and without complications, said Dr. Al Fauzi. Stem cell transplantation aiming to restore function in stroke is safe and feasible. Further randomized controlled trials are needed to evaluate its efficacy.

How Does Surgery for Cerebral Arteriovenous Malformation Affect Pulsatility and Resistance?

Embolization reduces flow in cerebral arteriovenous malformations (AVMs) before surgical resection, but changes in pulsatility index (PI) and resistance index (RI) are unknown. Sophia F. Shakur, MD, a neurosurgery resident at the University of Chicago Medical Center, and colleagues measured PI and RI in AVM arterial feeders before and after embolization or surgery.

The researchers reviewed the records of patients who underwent AVM embolization and surgical resection at a single institution between 2007 and 2014.Patients who had PI, RI, and flows obtained using quantitative magnetic resonance angiography were retrospectively reviewed. Hemodynamic parameters were compared between the feeder and contralateral artery before and after embolization or surgery.

Thirty-two patients with 48 feeder arteries underwent embolization (mean 1.3 sessions). Another 32 patients with 49 feeder arteries had surgery with or without preoperative embolization. Before treatment, flow volume rate and mean, systolic and diastolic flow velocities were significantly higher in feeders versus contralateral counterparts. PI and RI were significantly lower in feeder vessels, compared with contralateral vessels. After embolization, mean, systolic, and diastolic flow velocities increased significantly, but PI and RI did not change significantly. However, after surgery, mean, systolic, and diastolic flow velocities within feeders decreased significantly, and PI and RI normalized to match the indices of their contralateral counterparts.

Following partial AVM embolization, PI and RI were unchanged, and flow velocities in feeder arteries increased significantly, likely due to redistribution of flow through residual nidus. Complete surgical resection resulted in normalization of PI and RI and a concomitant decrease in flow velocities.

Temporal Evolution of ICP and PRx May Have Prognostic Significance

Studies of large cohorts of patients with traumatic brain injury (TBI) have shown that intracranial pressure (ICP) and the pressure reactivity index (PRx) are independently associated with patient outcome. How these parameters evolve over the course of the stay in an intensive care unit, and the question of whether this evolution has any prognostic importance, has not been well studied, however.

Hadie Adams, MD, a postdoctoral fellow at Johns Hopkins School of Medicine in Baltimore, and colleagues monitored ICP and PRx in 573 patients with severe TBI in a regional neurocritical care unit. Data were calculated in 12-hour epochs for the first 168 hours (ie, seven days) after the time of incident. Data were stratified by the presence of diffuse TBI (dTBI) or space occupying lesions (SOL), as well as by fatal or nonfatal outcome at six months post injury. Mixed linear modeling was used to assess change of ICP and PRx over time to detect differences in mortality.

Mean ICP peaked at between 24 hours and 36 hours after injury, but only in patients who died. The difference in mean ICP between patients with fatal and nonfatal outcome was significant for the first 120 hours after ictus. For PRx, patients with a fatal outcome also had higher (ie, more impaired) PRx throughout the first 168 hours after ictus. The separation of ICP and PRx was greatest in the first 72 hours after ictus. Also, mean differences of ICP and PRx between the outcome groups were more pronounced in patients with dTBI than those with SOL.

In this cohort of 573 patients with TBI and high-resolution physiologic data, ICP and PRx displayed a distinctive temporal evolution. Importantly, early ICP and PRx allowed for the clearest prognostic delineation, said Dr. Adams.

 

 

The optimal thresholds, prognostic significance, and clinical correlations of ICP and PRx are likely to be time-dependent, he added.

How Common Is Position-Related Neuropraxia In Spine Surgery?

Gurpreet Surinder Gandhoke, MD, a neurosurgeon in Pittsburgh, and colleagues examined the incidence of position-related neuropraxia in 4,489 consecutive patients undergoing spine surgery at a university hospital. Some patients in the group had peripheral nerve injury from positioning. The authors observed intraoperative monitoring (IOM) changes related to arm and leg positioning and calculated their sensitivity and specificity in predicting the development of a new position-related peripheral nerve injury. Impact of length of surgery and other variables, including age, sex, BMI, diabetes, hypertension, coronary artery disease, cardiovascular disease, and a history of smoking on the development of a new peripheral nerve injury were defined.

Patients were in the following positions: arms abducted and flexed at the elbow (64.7%), arms tucked at the side (35%), and the lateral position (0.3%). Thirteen of 4,489 patients developed a new positioning-related peripheral nerve deficit, 54% developed meralgia paresthetica, and 46% developed ulnar neuropathy.

Seventy-two patients (1.6%) developed IOM changes from positioning, and all of these patients underwent a repositioning maneuver. One of these 72 patients (1.3%) developed a new position-related nerve deficit. Of the 98.4% of patients who did not develop position-related IOM changes, 0.3% developed a new position-related nerve deficit.

Sensitivity of IOM to detect a new position-related nerve deficit was 7.69%, and the specificity was 98.41%. Neither length of surgery nor any analyzed patient-related variable significantly affected the development of a new neuropraxia. The incidence of a new position-related nerve deficit in spine surgery was less than 0.3%. IOM had high specificity and low sensitivity in detecting a positioning-related deficit.

Stem Cell Transplantation Is Safe in Hemorrhagic Stroke

Intraventricular transplantation using bone marrow mesenchymal stem cells is safe in patients with hemorrhagic stroke, according to research presented by Asra Al Fauzi, MD, a neurosurgeon at Soetomo General Hospital in Surabaya, Indonesia.

This study examined a group of eight patients with supratentorial hemorrhagic stroke. All patients had received six months of treatment and had stable neurologic deficits and NIH Stroke Scale (NIHSS) scores of five to 25. Clinical outcomes were measured using the NIHSS scale six months after transplantation. Bone marrow was aspirated and taken from the patient to whom it was to be administered under aseptic conditions. Expansion of mesenchymal stem cells took three to four weeks. All patients were administered a mean of 20 × 106 cells intraventricularly.

Results showed improvement of the NIHSS score in five patients after treatment; three patients had no change in status. No important adverse events associated with transplant or surgery were observed during a six-month follow up. The study demonstrates that bone marrow mesenchymal stem cell can be transplanted intraventricularly with excellent tolerance and without complications, said Dr. Al Fauzi. Stem cell transplantation aiming to restore function in stroke is safe and feasible. Further randomized controlled trials are needed to evaluate its efficacy.

How Does Surgery for Cerebral Arteriovenous Malformation Affect Pulsatility and Resistance?

Embolization reduces flow in cerebral arteriovenous malformations (AVMs) before surgical resection, but changes in pulsatility index (PI) and resistance index (RI) are unknown. Sophia F. Shakur, MD, a neurosurgery resident at the University of Chicago Medical Center, and colleagues measured PI and RI in AVM arterial feeders before and after embolization or surgery.

The researchers reviewed the records of patients who underwent AVM embolization and surgical resection at a single institution between 2007 and 2014.Patients who had PI, RI, and flows obtained using quantitative magnetic resonance angiography were retrospectively reviewed. Hemodynamic parameters were compared between the feeder and contralateral artery before and after embolization or surgery.

Thirty-two patients with 48 feeder arteries underwent embolization (mean 1.3 sessions). Another 32 patients with 49 feeder arteries had surgery with or without preoperative embolization. Before treatment, flow volume rate and mean, systolic and diastolic flow velocities were significantly higher in feeders versus contralateral counterparts. PI and RI were significantly lower in feeder vessels, compared with contralateral vessels. After embolization, mean, systolic, and diastolic flow velocities increased significantly, but PI and RI did not change significantly. However, after surgery, mean, systolic, and diastolic flow velocities within feeders decreased significantly, and PI and RI normalized to match the indices of their contralateral counterparts.

Following partial AVM embolization, PI and RI were unchanged, and flow velocities in feeder arteries increased significantly, likely due to redistribution of flow through residual nidus. Complete surgical resection resulted in normalization of PI and RI and a concomitant decrease in flow velocities.

Temporal Evolution of ICP and PRx May Have Prognostic Significance

Studies of large cohorts of patients with traumatic brain injury (TBI) have shown that intracranial pressure (ICP) and the pressure reactivity index (PRx) are independently associated with patient outcome. How these parameters evolve over the course of the stay in an intensive care unit, and the question of whether this evolution has any prognostic importance, has not been well studied, however.

Hadie Adams, MD, a postdoctoral fellow at Johns Hopkins School of Medicine in Baltimore, and colleagues monitored ICP and PRx in 573 patients with severe TBI in a regional neurocritical care unit. Data were calculated in 12-hour epochs for the first 168 hours (ie, seven days) after the time of incident. Data were stratified by the presence of diffuse TBI (dTBI) or space occupying lesions (SOL), as well as by fatal or nonfatal outcome at six months post injury. Mixed linear modeling was used to assess change of ICP and PRx over time to detect differences in mortality.

Mean ICP peaked at between 24 hours and 36 hours after injury, but only in patients who died. The difference in mean ICP between patients with fatal and nonfatal outcome was significant for the first 120 hours after ictus. For PRx, patients with a fatal outcome also had higher (ie, more impaired) PRx throughout the first 168 hours after ictus. The separation of ICP and PRx was greatest in the first 72 hours after ictus. Also, mean differences of ICP and PRx between the outcome groups were more pronounced in patients with dTBI than those with SOL.

In this cohort of 573 patients with TBI and high-resolution physiologic data, ICP and PRx displayed a distinctive temporal evolution. Importantly, early ICP and PRx allowed for the clearest prognostic delineation, said Dr. Adams.

 

 

The optimal thresholds, prognostic significance, and clinical correlations of ICP and PRx are likely to be time-dependent, he added.

How Common Is Position-Related Neuropraxia In Spine Surgery?

Gurpreet Surinder Gandhoke, MD, a neurosurgeon in Pittsburgh, and colleagues examined the incidence of position-related neuropraxia in 4,489 consecutive patients undergoing spine surgery at a university hospital. Some patients in the group had peripheral nerve injury from positioning. The authors observed intraoperative monitoring (IOM) changes related to arm and leg positioning and calculated their sensitivity and specificity in predicting the development of a new position-related peripheral nerve injury. Impact of length of surgery and other variables, including age, sex, BMI, diabetes, hypertension, coronary artery disease, cardiovascular disease, and a history of smoking on the development of a new peripheral nerve injury were defined.

Patients were in the following positions: arms abducted and flexed at the elbow (64.7%), arms tucked at the side (35%), and the lateral position (0.3%). Thirteen of 4,489 patients developed a new positioning-related peripheral nerve deficit, 54% developed meralgia paresthetica, and 46% developed ulnar neuropathy.

Seventy-two patients (1.6%) developed IOM changes from positioning, and all of these patients underwent a repositioning maneuver. One of these 72 patients (1.3%) developed a new position-related nerve deficit. Of the 98.4% of patients who did not develop position-related IOM changes, 0.3% developed a new position-related nerve deficit.

Sensitivity of IOM to detect a new position-related nerve deficit was 7.69%, and the specificity was 98.41%. Neither length of surgery nor any analyzed patient-related variable significantly affected the development of a new neuropraxia. The incidence of a new position-related nerve deficit in spine surgery was less than 0.3%. IOM had high specificity and low sensitivity in detecting a positioning-related deficit.

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Looking Beyond Rest to Active and Targeted Treatments for Concussion

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VANCOUVER—Prescribed rest is an important component of treating concussion, but it may not be the most appropriate intervention for all patients and may worsen symptoms in some cases, said Anthony P. Kontos, PhD, at the 68th Annual Meeting of the American Academy of Neurology (AAN).

Anthony P. Kontos, PhD

“We need to move the discussion on concussion toward more active and targeted treatments,” said Dr. Kontos, Research Director of the University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program.Concussion is a heterogeneous injury with varying clinical profiles and recovery trajectories. Approaches to treatment should account for these differences and involve multidisciplinary teams when necessary, he said.

In October 2015, Dr. Kontos, Michael “Micky” Collins, PhD, and David O. Okonkwo, MD, PhD, directed a meeting with 37 participants from the fields of neurology, neuropsychology, neurosurgery, primary care, athletic training, and physical therapy to create a summary agreement that can assist clinicians with concussion treatment.

Nineteen guests, including representatives from professional sports organizations, the military, and public health, also attended the Targeted Evaluation and Active Management (TEAM) Approach to Treating Concussion meeting. The National Football League and UPMC sponsored the meeting, which was held in Pittsburgh.

Consensus documents have predominantly focused on things like the various definitions of concussion, how to assess concussion, and how to manage it, said Dr. Kontos. “We really wanted to focus on more of that end point of treatment and potentially more active treatment,” he said.

The TEAM participants developed and agreed upon 17 statements, which they plan to publish. At the AAN meeting, Dr. Kontos provided a brief review of some of the statements and discussed them in the context of recent research.

Rest’s Benefits and Limitations

Physical and cognitive rest, as part of an individualized treatment plan, are currently “the foundation of sport-related concussion management,” according to National Collegiate Athletic Association interassociation concussion guidelines. Rest after concussion conserves needed energy in the brain and reduces the likelihood of second impact syndrome and other catastrophic events, Dr. Kontos said. Furthermore, some studies have suggested that rest improves recovery. Brown et al reported in 2014 that athletes who self-reported more cognitive activity after a concussion took longer to recover than those who reported less cognitive activity.

However, the evidence to support rest is limited. In 2013, the Institute of Medicine and National Research Council published a report on sports-related concussion in youth that found little evidence regarding the efficacy of rest following concussion or to inform the best timing and approach for return to activity. Their statement “still resonates now,” Dr. Kontos said. “There’s very little empirical data to support what we do with rest. It’s largely an across-the-board policy that’s not data-driven, and we need to change that.” The TEAM group agreed “there is limited empirical evidence for the effectiveness of prescribed physical and cognitive rest, with no multisite trials for prescribed rest following concussion.”

Prescribed rest can have psychologic consequences, including emotional distress, depression, and anxiety. Rest allows individuals time to ruminate on their injury, which can exacerbate symptoms in self-report. Individuals who somaticize are particularly vulnerable to this effect. Jeremy M. Root, MD, of Children’s National Medical Center in Washington, DC, Dr. Kontos, and colleagues reported in April in the Journal of Pediatrics that patients who had high somatization scores were approximately five to seven times more likely to report an increase in symptoms at two weeks and four weeks, compared with those who were not in the highest quartile of somatization.

In addition, patients who are prescribed rest may think, “Wow, I must have a really bad injury such that I can’t do anything for a week.” This contextual framing effect may also influence the outcome, said Dr. Kontos.

Thomas et al in 2015 published the results of a randomized controlled trial that found that, after a concussion, patients ages 11 to 22 who were prescribed five days’ rest reported more daily postconcussive symptoms, compared with patients who were prescribed two days’ rest with progressive return to activity. Symptoms peaked at four days, and differences between groups remained at 10 days. “They have higher symptoms when they’re told to rest longer than if they’re told to rest less,” Dr. Kontos said. Clinically, there was no significant difference between groups in neurocognitive or balance outcomes, however.

The effect of treatment on the number of postconcussive symptoms may not be that straightforward, however. When Dr. Kontos, Dr. Thomas, and colleagues reanalyzed the data to look at patients who only reported symptoms (eg, headache, nausea, dizziness) but did not otherwise have early signs of concussion (eg, loss of consciousness, posttraumatic amnesia, disorientation, confusion), the symptoms-only group reported more symptoms at 10 days when prescribed five days’ rest, compared with two days’ rest with progressive return to activity. Patients who had early signs of concussion, however, reported fewer symptoms when prescribed five days’ rest versus two days’ rest with progressive return to activity.

 

 

“We have a sort of dichotomy here. We don’t want to say rest is bad. It may be very good for these people who have a high organic level or severity to their injury, and we may need to think in terms of resting them longer, whereas these patients [with symptoms only] certainly need to get more active, probably earlier in the process,” Dr. Kontos said.

Activity and social interaction may provide benefits. Miller et al in 2013 reported that environmental enrichment, including cognitive, physical, and social activity, is associated with improved outcome and sparing of hippocampal atrophy in the chronic stages of traumatic brain injury.

The TEAM group agreed, “Active treatment strategies may be initiated early in recovery following concussion.” The group also agreed, “strict brain rest (eg, ‘cocoon’ therapy) is not indicated and may have detrimental effects on patients following concussion.”

A Heterogeneous Injury

A focal point of the TEAM meeting was the concept of various clinical profiles of concussion. The group agreed, “Concussions are characterized by diverse symptoms and impairments in function resulting in different clinical profiles and recovery trajectories.”

“We need to think in terms of what type of concussion does this individual have and is it multiple types,” such as cognitive-fatigue, vestibular, or ocular, said Dr. Kontos. “We don’t typically just see one of these.” For example, a patient may have a predominant vestibular concussion with some posttraumatic migraine and neck involvement. “Oftentimes we see misdiagnoses when people show up. They’ve been diagnosed with cognitive issues when in reality they’re having vision or oculomotor difficulties.”

There are many potential approaches to categorizing, classifying, or profiling concussion, including those that consider posttraumatic mood and migraine as modifying factors, he said.

Multidisciplinary Teams

In addition, the TEAM group stated, “thorough multidomain assessment is warranted to properly evaluate the clinical profiles of concussion.” Various experts may be needed to assess cognitive, exertional, oculomotor, vestibular, and other symptoms and impairment.

As part of a multidisciplinary team, a neurologist, neuropsychologist, or primary care physician could “serve as kind of a point guard, to use a basketball analogy,” said Dr. Kontos. When an aspect of a patient’s assessment or treatment needs to be addressed more in depth, such as with regard to medication, vestibular therapy, or imaging, the patient may be referred to experts in those areas. “We try to work as a team and work back through the point guard to coordinate that care system,” he said. Telemedicine might allow for multidisciplinary treatment in remote geographic areas where establishing multidisciplinary teams otherwise might not be feasible, Dr. Kontos noted.

“Pharmacological therapy may be indicated in selected circumstances to treat certain symptoms and impairments related to concussion,” the TEAM group agreed.There is “very little” evidence for medicine in concussion, and drugs can exacerbate symptoms in some situations, Dr. Kontos said. Randomized controlled trials will help researchers better understand medication’s role in treating concussion.

More Active Treatment

In particular, patients who do not receive appropriate management after a concussion and then go to a clinic several months later with chronic symptoms may benefit from more active approaches to treatment, such as brisk walking.

Dr. Kontos described the case of an ice hockey player who was prescribed rest following a first concussion. After resting, the athlete began a return-to-play protocol that focused on aerobic exertion with no dynamic movements. As soon as the player returned to the ice, however, dizziness and headache came flooding back.

Several months later, the athlete was referred to a concussion clinic. The patient underwent a thorough evaluation that included vestibular and oculomotor assessments. Clinicians determined that the athlete needed more active treatment, including vision training and walking with head movements. In three weeks, the athlete returned to the ice. About a week later, the athlete resumed full-contact ice hockey.

“Prescribing rest is not the only approach,” Dr. Kontos said. “We need to move the discussion in different directions. We need to be more active with certain people and we need to be more targeted with our approaches.”

Jake Remaly

References

Suggested Reading
Brown NJ, Mannix RC, O’Brien MJ, et al. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014;133(2):e299-304.
Miller LS, Colella B, Mikulis D, et al. Environmental enrichment may protect against hippocampal atrophy in the chronic stages of traumatic brain injury. Front Hum Neurosci. 2013;7:506.
Root JM, Zuckerbraun NS, Wang L, et al. History of somatization is associated with prolonged recovery from concussion. J Pediatr. 2016 Apr 5 [Epub ahead of print].
Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135(2):213-223.

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VANCOUVER—Prescribed rest is an important component of treating concussion, but it may not be the most appropriate intervention for all patients and may worsen symptoms in some cases, said Anthony P. Kontos, PhD, at the 68th Annual Meeting of the American Academy of Neurology (AAN).

Anthony P. Kontos, PhD

“We need to move the discussion on concussion toward more active and targeted treatments,” said Dr. Kontos, Research Director of the University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program.Concussion is a heterogeneous injury with varying clinical profiles and recovery trajectories. Approaches to treatment should account for these differences and involve multidisciplinary teams when necessary, he said.

In October 2015, Dr. Kontos, Michael “Micky” Collins, PhD, and David O. Okonkwo, MD, PhD, directed a meeting with 37 participants from the fields of neurology, neuropsychology, neurosurgery, primary care, athletic training, and physical therapy to create a summary agreement that can assist clinicians with concussion treatment.

Nineteen guests, including representatives from professional sports organizations, the military, and public health, also attended the Targeted Evaluation and Active Management (TEAM) Approach to Treating Concussion meeting. The National Football League and UPMC sponsored the meeting, which was held in Pittsburgh.

Consensus documents have predominantly focused on things like the various definitions of concussion, how to assess concussion, and how to manage it, said Dr. Kontos. “We really wanted to focus on more of that end point of treatment and potentially more active treatment,” he said.

The TEAM participants developed and agreed upon 17 statements, which they plan to publish. At the AAN meeting, Dr. Kontos provided a brief review of some of the statements and discussed them in the context of recent research.

Rest’s Benefits and Limitations

Physical and cognitive rest, as part of an individualized treatment plan, are currently “the foundation of sport-related concussion management,” according to National Collegiate Athletic Association interassociation concussion guidelines. Rest after concussion conserves needed energy in the brain and reduces the likelihood of second impact syndrome and other catastrophic events, Dr. Kontos said. Furthermore, some studies have suggested that rest improves recovery. Brown et al reported in 2014 that athletes who self-reported more cognitive activity after a concussion took longer to recover than those who reported less cognitive activity.

However, the evidence to support rest is limited. In 2013, the Institute of Medicine and National Research Council published a report on sports-related concussion in youth that found little evidence regarding the efficacy of rest following concussion or to inform the best timing and approach for return to activity. Their statement “still resonates now,” Dr. Kontos said. “There’s very little empirical data to support what we do with rest. It’s largely an across-the-board policy that’s not data-driven, and we need to change that.” The TEAM group agreed “there is limited empirical evidence for the effectiveness of prescribed physical and cognitive rest, with no multisite trials for prescribed rest following concussion.”

Prescribed rest can have psychologic consequences, including emotional distress, depression, and anxiety. Rest allows individuals time to ruminate on their injury, which can exacerbate symptoms in self-report. Individuals who somaticize are particularly vulnerable to this effect. Jeremy M. Root, MD, of Children’s National Medical Center in Washington, DC, Dr. Kontos, and colleagues reported in April in the Journal of Pediatrics that patients who had high somatization scores were approximately five to seven times more likely to report an increase in symptoms at two weeks and four weeks, compared with those who were not in the highest quartile of somatization.

In addition, patients who are prescribed rest may think, “Wow, I must have a really bad injury such that I can’t do anything for a week.” This contextual framing effect may also influence the outcome, said Dr. Kontos.

Thomas et al in 2015 published the results of a randomized controlled trial that found that, after a concussion, patients ages 11 to 22 who were prescribed five days’ rest reported more daily postconcussive symptoms, compared with patients who were prescribed two days’ rest with progressive return to activity. Symptoms peaked at four days, and differences between groups remained at 10 days. “They have higher symptoms when they’re told to rest longer than if they’re told to rest less,” Dr. Kontos said. Clinically, there was no significant difference between groups in neurocognitive or balance outcomes, however.

The effect of treatment on the number of postconcussive symptoms may not be that straightforward, however. When Dr. Kontos, Dr. Thomas, and colleagues reanalyzed the data to look at patients who only reported symptoms (eg, headache, nausea, dizziness) but did not otherwise have early signs of concussion (eg, loss of consciousness, posttraumatic amnesia, disorientation, confusion), the symptoms-only group reported more symptoms at 10 days when prescribed five days’ rest, compared with two days’ rest with progressive return to activity. Patients who had early signs of concussion, however, reported fewer symptoms when prescribed five days’ rest versus two days’ rest with progressive return to activity.

 

 

“We have a sort of dichotomy here. We don’t want to say rest is bad. It may be very good for these people who have a high organic level or severity to their injury, and we may need to think in terms of resting them longer, whereas these patients [with symptoms only] certainly need to get more active, probably earlier in the process,” Dr. Kontos said.

Activity and social interaction may provide benefits. Miller et al in 2013 reported that environmental enrichment, including cognitive, physical, and social activity, is associated with improved outcome and sparing of hippocampal atrophy in the chronic stages of traumatic brain injury.

The TEAM group agreed, “Active treatment strategies may be initiated early in recovery following concussion.” The group also agreed, “strict brain rest (eg, ‘cocoon’ therapy) is not indicated and may have detrimental effects on patients following concussion.”

A Heterogeneous Injury

A focal point of the TEAM meeting was the concept of various clinical profiles of concussion. The group agreed, “Concussions are characterized by diverse symptoms and impairments in function resulting in different clinical profiles and recovery trajectories.”

“We need to think in terms of what type of concussion does this individual have and is it multiple types,” such as cognitive-fatigue, vestibular, or ocular, said Dr. Kontos. “We don’t typically just see one of these.” For example, a patient may have a predominant vestibular concussion with some posttraumatic migraine and neck involvement. “Oftentimes we see misdiagnoses when people show up. They’ve been diagnosed with cognitive issues when in reality they’re having vision or oculomotor difficulties.”

There are many potential approaches to categorizing, classifying, or profiling concussion, including those that consider posttraumatic mood and migraine as modifying factors, he said.

Multidisciplinary Teams

In addition, the TEAM group stated, “thorough multidomain assessment is warranted to properly evaluate the clinical profiles of concussion.” Various experts may be needed to assess cognitive, exertional, oculomotor, vestibular, and other symptoms and impairment.

As part of a multidisciplinary team, a neurologist, neuropsychologist, or primary care physician could “serve as kind of a point guard, to use a basketball analogy,” said Dr. Kontos. When an aspect of a patient’s assessment or treatment needs to be addressed more in depth, such as with regard to medication, vestibular therapy, or imaging, the patient may be referred to experts in those areas. “We try to work as a team and work back through the point guard to coordinate that care system,” he said. Telemedicine might allow for multidisciplinary treatment in remote geographic areas where establishing multidisciplinary teams otherwise might not be feasible, Dr. Kontos noted.

“Pharmacological therapy may be indicated in selected circumstances to treat certain symptoms and impairments related to concussion,” the TEAM group agreed.There is “very little” evidence for medicine in concussion, and drugs can exacerbate symptoms in some situations, Dr. Kontos said. Randomized controlled trials will help researchers better understand medication’s role in treating concussion.

More Active Treatment

In particular, patients who do not receive appropriate management after a concussion and then go to a clinic several months later with chronic symptoms may benefit from more active approaches to treatment, such as brisk walking.

Dr. Kontos described the case of an ice hockey player who was prescribed rest following a first concussion. After resting, the athlete began a return-to-play protocol that focused on aerobic exertion with no dynamic movements. As soon as the player returned to the ice, however, dizziness and headache came flooding back.

Several months later, the athlete was referred to a concussion clinic. The patient underwent a thorough evaluation that included vestibular and oculomotor assessments. Clinicians determined that the athlete needed more active treatment, including vision training and walking with head movements. In three weeks, the athlete returned to the ice. About a week later, the athlete resumed full-contact ice hockey.

“Prescribing rest is not the only approach,” Dr. Kontos said. “We need to move the discussion in different directions. We need to be more active with certain people and we need to be more targeted with our approaches.”

Jake Remaly

VANCOUVER—Prescribed rest is an important component of treating concussion, but it may not be the most appropriate intervention for all patients and may worsen symptoms in some cases, said Anthony P. Kontos, PhD, at the 68th Annual Meeting of the American Academy of Neurology (AAN).

Anthony P. Kontos, PhD

“We need to move the discussion on concussion toward more active and targeted treatments,” said Dr. Kontos, Research Director of the University of Pittsburgh Medical Center (UPMC) Sports Medicine Concussion Program.Concussion is a heterogeneous injury with varying clinical profiles and recovery trajectories. Approaches to treatment should account for these differences and involve multidisciplinary teams when necessary, he said.

In October 2015, Dr. Kontos, Michael “Micky” Collins, PhD, and David O. Okonkwo, MD, PhD, directed a meeting with 37 participants from the fields of neurology, neuropsychology, neurosurgery, primary care, athletic training, and physical therapy to create a summary agreement that can assist clinicians with concussion treatment.

Nineteen guests, including representatives from professional sports organizations, the military, and public health, also attended the Targeted Evaluation and Active Management (TEAM) Approach to Treating Concussion meeting. The National Football League and UPMC sponsored the meeting, which was held in Pittsburgh.

Consensus documents have predominantly focused on things like the various definitions of concussion, how to assess concussion, and how to manage it, said Dr. Kontos. “We really wanted to focus on more of that end point of treatment and potentially more active treatment,” he said.

The TEAM participants developed and agreed upon 17 statements, which they plan to publish. At the AAN meeting, Dr. Kontos provided a brief review of some of the statements and discussed them in the context of recent research.

Rest’s Benefits and Limitations

Physical and cognitive rest, as part of an individualized treatment plan, are currently “the foundation of sport-related concussion management,” according to National Collegiate Athletic Association interassociation concussion guidelines. Rest after concussion conserves needed energy in the brain and reduces the likelihood of second impact syndrome and other catastrophic events, Dr. Kontos said. Furthermore, some studies have suggested that rest improves recovery. Brown et al reported in 2014 that athletes who self-reported more cognitive activity after a concussion took longer to recover than those who reported less cognitive activity.

However, the evidence to support rest is limited. In 2013, the Institute of Medicine and National Research Council published a report on sports-related concussion in youth that found little evidence regarding the efficacy of rest following concussion or to inform the best timing and approach for return to activity. Their statement “still resonates now,” Dr. Kontos said. “There’s very little empirical data to support what we do with rest. It’s largely an across-the-board policy that’s not data-driven, and we need to change that.” The TEAM group agreed “there is limited empirical evidence for the effectiveness of prescribed physical and cognitive rest, with no multisite trials for prescribed rest following concussion.”

Prescribed rest can have psychologic consequences, including emotional distress, depression, and anxiety. Rest allows individuals time to ruminate on their injury, which can exacerbate symptoms in self-report. Individuals who somaticize are particularly vulnerable to this effect. Jeremy M. Root, MD, of Children’s National Medical Center in Washington, DC, Dr. Kontos, and colleagues reported in April in the Journal of Pediatrics that patients who had high somatization scores were approximately five to seven times more likely to report an increase in symptoms at two weeks and four weeks, compared with those who were not in the highest quartile of somatization.

In addition, patients who are prescribed rest may think, “Wow, I must have a really bad injury such that I can’t do anything for a week.” This contextual framing effect may also influence the outcome, said Dr. Kontos.

Thomas et al in 2015 published the results of a randomized controlled trial that found that, after a concussion, patients ages 11 to 22 who were prescribed five days’ rest reported more daily postconcussive symptoms, compared with patients who were prescribed two days’ rest with progressive return to activity. Symptoms peaked at four days, and differences between groups remained at 10 days. “They have higher symptoms when they’re told to rest longer than if they’re told to rest less,” Dr. Kontos said. Clinically, there was no significant difference between groups in neurocognitive or balance outcomes, however.

The effect of treatment on the number of postconcussive symptoms may not be that straightforward, however. When Dr. Kontos, Dr. Thomas, and colleagues reanalyzed the data to look at patients who only reported symptoms (eg, headache, nausea, dizziness) but did not otherwise have early signs of concussion (eg, loss of consciousness, posttraumatic amnesia, disorientation, confusion), the symptoms-only group reported more symptoms at 10 days when prescribed five days’ rest, compared with two days’ rest with progressive return to activity. Patients who had early signs of concussion, however, reported fewer symptoms when prescribed five days’ rest versus two days’ rest with progressive return to activity.

 

 

“We have a sort of dichotomy here. We don’t want to say rest is bad. It may be very good for these people who have a high organic level or severity to their injury, and we may need to think in terms of resting them longer, whereas these patients [with symptoms only] certainly need to get more active, probably earlier in the process,” Dr. Kontos said.

Activity and social interaction may provide benefits. Miller et al in 2013 reported that environmental enrichment, including cognitive, physical, and social activity, is associated with improved outcome and sparing of hippocampal atrophy in the chronic stages of traumatic brain injury.

The TEAM group agreed, “Active treatment strategies may be initiated early in recovery following concussion.” The group also agreed, “strict brain rest (eg, ‘cocoon’ therapy) is not indicated and may have detrimental effects on patients following concussion.”

A Heterogeneous Injury

A focal point of the TEAM meeting was the concept of various clinical profiles of concussion. The group agreed, “Concussions are characterized by diverse symptoms and impairments in function resulting in different clinical profiles and recovery trajectories.”

“We need to think in terms of what type of concussion does this individual have and is it multiple types,” such as cognitive-fatigue, vestibular, or ocular, said Dr. Kontos. “We don’t typically just see one of these.” For example, a patient may have a predominant vestibular concussion with some posttraumatic migraine and neck involvement. “Oftentimes we see misdiagnoses when people show up. They’ve been diagnosed with cognitive issues when in reality they’re having vision or oculomotor difficulties.”

There are many potential approaches to categorizing, classifying, or profiling concussion, including those that consider posttraumatic mood and migraine as modifying factors, he said.

Multidisciplinary Teams

In addition, the TEAM group stated, “thorough multidomain assessment is warranted to properly evaluate the clinical profiles of concussion.” Various experts may be needed to assess cognitive, exertional, oculomotor, vestibular, and other symptoms and impairment.

As part of a multidisciplinary team, a neurologist, neuropsychologist, or primary care physician could “serve as kind of a point guard, to use a basketball analogy,” said Dr. Kontos. When an aspect of a patient’s assessment or treatment needs to be addressed more in depth, such as with regard to medication, vestibular therapy, or imaging, the patient may be referred to experts in those areas. “We try to work as a team and work back through the point guard to coordinate that care system,” he said. Telemedicine might allow for multidisciplinary treatment in remote geographic areas where establishing multidisciplinary teams otherwise might not be feasible, Dr. Kontos noted.

“Pharmacological therapy may be indicated in selected circumstances to treat certain symptoms and impairments related to concussion,” the TEAM group agreed.There is “very little” evidence for medicine in concussion, and drugs can exacerbate symptoms in some situations, Dr. Kontos said. Randomized controlled trials will help researchers better understand medication’s role in treating concussion.

More Active Treatment

In particular, patients who do not receive appropriate management after a concussion and then go to a clinic several months later with chronic symptoms may benefit from more active approaches to treatment, such as brisk walking.

Dr. Kontos described the case of an ice hockey player who was prescribed rest following a first concussion. After resting, the athlete began a return-to-play protocol that focused on aerobic exertion with no dynamic movements. As soon as the player returned to the ice, however, dizziness and headache came flooding back.

Several months later, the athlete was referred to a concussion clinic. The patient underwent a thorough evaluation that included vestibular and oculomotor assessments. Clinicians determined that the athlete needed more active treatment, including vision training and walking with head movements. In three weeks, the athlete returned to the ice. About a week later, the athlete resumed full-contact ice hockey.

“Prescribing rest is not the only approach,” Dr. Kontos said. “We need to move the discussion in different directions. We need to be more active with certain people and we need to be more targeted with our approaches.”

Jake Remaly

References

Suggested Reading
Brown NJ, Mannix RC, O’Brien MJ, et al. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014;133(2):e299-304.
Miller LS, Colella B, Mikulis D, et al. Environmental enrichment may protect against hippocampal atrophy in the chronic stages of traumatic brain injury. Front Hum Neurosci. 2013;7:506.
Root JM, Zuckerbraun NS, Wang L, et al. History of somatization is associated with prolonged recovery from concussion. J Pediatr. 2016 Apr 5 [Epub ahead of print].
Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135(2):213-223.

References

Suggested Reading
Brown NJ, Mannix RC, O’Brien MJ, et al. Effect of cognitive activity level on duration of post-concussion symptoms. Pediatrics. 2014;133(2):e299-304.
Miller LS, Colella B, Mikulis D, et al. Environmental enrichment may protect against hippocampal atrophy in the chronic stages of traumatic brain injury. Front Hum Neurosci. 2013;7:506.
Root JM, Zuckerbraun NS, Wang L, et al. History of somatization is associated with prolonged recovery from concussion. J Pediatr. 2016 Apr 5 [Epub ahead of print].
Thomas DG, Apps JN, Hoffmann RG, et al. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015;135(2):213-223.

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English Proficiency May Influence King-Devick Score

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VANCOUVER—Language proficiency affects a person’s results on the King-Devick concussion screening test, according to research presented at the 68th Annual Meeting of the American Academy of Neurology. In a study at New York University (NYU), it took 27 healthy, native English-speaking volunteers 42.8 seconds to complete the test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers for whom English was a second language 54.4 seconds to complete the test. Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at NYU.

Katharine Dempsey

The King-Devick test is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed as they read out loud and in English three sets of 40 numbers. Each set is progressively more difficult to read. The test is administered by flash cards or, as in the study, by computer.

In all, 18 languages were spoken by the group of non-native English speakers. The most common native languages in this group were Spanish and Chinese. All of the non-native speakers at NYU were proficient in English, but their native languages were often dominant, meaning that they were used at home and to perform mental arithmetic. Some subjects did not use Arabic numerals or read from right to left in their native tongues.

Instructions for the King-Devick tool recommend comparing subjects’ performance with their own preseason baseline scores; the NYU findings emphasize the importance of this technique when subjects aren’t native English speakers. The investigators point out that when baseline scores are unavailable, non-native English speakers may be scored against reference ranges for native speakers.“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The researchers also tracked eye movements during testing. Non-native speakers had more saccades (149 vs 135), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs 288.0 milliseconds). Lag time correlated with native language dominance and suggests longer processing time.

The next step for research is to test how well patients perform on the King-Devick test in their native languages, Ms. Dempsey said.

M. Alexander Otto

References

Suggested Reading
Galetta KM, Barrett J, Allen M, et al. The King-Devick test as a determinant of head trauma and concussion in boxers and MMA fighters. Neurology. 2011;76(17):1456-1462.

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VANCOUVER—Language proficiency affects a person’s results on the King-Devick concussion screening test, according to research presented at the 68th Annual Meeting of the American Academy of Neurology. In a study at New York University (NYU), it took 27 healthy, native English-speaking volunteers 42.8 seconds to complete the test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers for whom English was a second language 54.4 seconds to complete the test. Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at NYU.

Katharine Dempsey

The King-Devick test is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed as they read out loud and in English three sets of 40 numbers. Each set is progressively more difficult to read. The test is administered by flash cards or, as in the study, by computer.

In all, 18 languages were spoken by the group of non-native English speakers. The most common native languages in this group were Spanish and Chinese. All of the non-native speakers at NYU were proficient in English, but their native languages were often dominant, meaning that they were used at home and to perform mental arithmetic. Some subjects did not use Arabic numerals or read from right to left in their native tongues.

Instructions for the King-Devick tool recommend comparing subjects’ performance with their own preseason baseline scores; the NYU findings emphasize the importance of this technique when subjects aren’t native English speakers. The investigators point out that when baseline scores are unavailable, non-native English speakers may be scored against reference ranges for native speakers.“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The researchers also tracked eye movements during testing. Non-native speakers had more saccades (149 vs 135), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs 288.0 milliseconds). Lag time correlated with native language dominance and suggests longer processing time.

The next step for research is to test how well patients perform on the King-Devick test in their native languages, Ms. Dempsey said.

M. Alexander Otto

VANCOUVER—Language proficiency affects a person’s results on the King-Devick concussion screening test, according to research presented at the 68th Annual Meeting of the American Academy of Neurology. In a study at New York University (NYU), it took 27 healthy, native English-speaking volunteers 42.8 seconds to complete the test, which is about average for nonconcussed subjects.

However, it took 27 other volunteers for whom English was a second language 54.4 seconds to complete the test. Had the test been given on the sidelines instead of in a laboratory, the extra 12 seconds might easily have been mistaken as a sign of serious concussion because concussions generally add about 5 seconds to the King-Devick score.

“A prolongation of 12 seconds in non-native English speakers has real clinical implications,” said lead investigator Katharine Dempsey, a medical student and member of the eye movement research team in the department of neurology at NYU.

Katharine Dempsey

The King-Devick test is an increasingly popular sideline screening tool used widely in professional sports. Subjects are timed as they read out loud and in English three sets of 40 numbers. Each set is progressively more difficult to read. The test is administered by flash cards or, as in the study, by computer.

In all, 18 languages were spoken by the group of non-native English speakers. The most common native languages in this group were Spanish and Chinese. All of the non-native speakers at NYU were proficient in English, but their native languages were often dominant, meaning that they were used at home and to perform mental arithmetic. Some subjects did not use Arabic numerals or read from right to left in their native tongues.

Instructions for the King-Devick tool recommend comparing subjects’ performance with their own preseason baseline scores; the NYU findings emphasize the importance of this technique when subjects aren’t native English speakers. The investigators point out that when baseline scores are unavailable, non-native English speakers may be scored against reference ranges for native speakers.“There’s incredible utility in using a sideline concussion screening test, but we definitely have to get out the message that the best practice is to take an athlete’s own preseason baseline. We have to be incredibly cautious when comparing test times of non-native English speakers to a normative database for native speakers,” Ms. Dempsey said.

The participants were in their early 30s, on average, and had no histories of concussion. The majority were women, and most were NYU employees or their friends.

The researchers also tracked eye movements during testing. Non-native speakers had more saccades (149 vs 135), but also fixated longer on numbers before initiating eye movement (345.4 milliseconds vs 288.0 milliseconds). Lag time correlated with native language dominance and suggests longer processing time.

The next step for research is to test how well patients perform on the King-Devick test in their native languages, Ms. Dempsey said.

M. Alexander Otto

References

Suggested Reading
Galetta KM, Barrett J, Allen M, et al. The King-Devick test as a determinant of head trauma and concussion in boxers and MMA fighters. Neurology. 2011;76(17):1456-1462.

References

Suggested Reading
Galetta KM, Barrett J, Allen M, et al. The King-Devick test as a determinant of head trauma and concussion in boxers and MMA fighters. Neurology. 2011;76(17):1456-1462.

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Blood Test Detects Concussion Up to One Week Later

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Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

Glenn S. Williams

References

Suggested Reading
Papa L, Brophy GM, Welch RD, et al. Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].
Bogoslovsky T, Diaz-Arrastia R. Dissecting temporal profiles of neuronal and axonal damage after mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].

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Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

Glenn S. Williams

Doctors can detect evidence of a concussion up to one week after a patient is injured by using a simple blood test, according to a report published online ahead of print March 28 in JAMA Neurology. Researchers tested two blood biomarkers—glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)—separately and together in patients with mild and moderate traumatic brain injury (TBI) within seven days of the injury. They examined the blood biomarkers with respect to diagnostic precision of TBI, presence of traumatic intracranial lesions detectable by CT, and need for neurosurgical intervention. Linda Papa, MDCM, MSc, and colleagues reported that GFAP performed consistently in detecting mild to moderate TBI, CT lesions, and the need for neurosurgical interventions across seven days. UCH-L1, they said, performed best in the early postinjury period.

Linda Papa, MDCM, MSc

“We have so many diagnostic blood tests for different parts of the body, like the heart, liver and kidneys, but there’s never been a reliable blood test to identify trauma in the brain,” said Dr. Papa, an emergency medicine physician at Orlando Health in Florid and lead author of the study. “We think this particular test could change that.”

Dr. Papa and colleagues designed a prospective cohort study that enrolled adults with trauma seen at a level 1 trauma center from March 1, 2010, to March 5, 2014. All patients underwent screening to determine whether they had experienced mild or moderate TBI, which was defined as blunt head trauma with loss of consciousness, amnesia, or disorientation and a Glasgow Coma Scale score of 9 to 15. Of 3,025 patients assessed, 1,030 met eligibility criteria for enrollment; 446 declined participation. Initial blood samples were obtained in 584 patients enrolled within four hours of injury. Repeated blood sampling was conducted every four hours up to 24 hours postinjury, and then every 12 hours thereafter until 180 hours postinjury.

A total of 1,831 blood samples were drawn from 584 patients (mean age, 40; 62% male) over seven days. Both GFAP and UCH-L1 were detectible within one hour of injury. GFAP peaked at 20 hours postinjury and slowly declined over 72 hours. UCH-L1 rose rapidly and peaked at eight hours postinjury, then declined rapidly over 48 hours.

Over the course of one week, GFAP demonstrated a diagnostic range of areas under the curve for detecting mild to moderate TBI of 0.73 to 0.94, and UCH-L1 demonstrated a diagnostic range of 0.30 to 0.67. For detecting intracranial lesions on CT, the diagnostic ranges of areas under the curve were 0.80 to 0.97 for GFAP and 0.31 to 0.77 for UCH-L1. For distinguishing patients with and without the need for a neurosurgical intervention, the range for GFAP was 0.91 to 100 and the range for UCH-L1 was 0.50 to 0.92.

“In the context of developing a point-of-care test, the early and rapid rise of UCH-L1 could be used to detect TBI immediately at the scene of injury in settings such as in the ambulance, on the playing field, or at the battlefield,” the researchers wrote. “The longer half-life of GFAP makes it a favorable biomarker to use in both the acute and subacute phases of injury because it is able to detect CT lesions for up to seven days after injury. Although its rise is not as rapid as [that of] UCH-L1, it performs well for detecting mild TBI and CT lesions within one hour of injury.”

Glenn S. Williams

References

Suggested Reading
Papa L, Brophy GM, Welch RD, et al. Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].
Bogoslovsky T, Diaz-Arrastia R. Dissecting temporal profiles of neuronal and axonal damage after mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].

References

Suggested Reading
Papa L, Brophy GM, Welch RD, et al. Time course and diagnostic accuracy of glial and neuronal blood biomarkers GFAP and UCH-L1 in a large cohort of trauma patients with and without mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].
Bogoslovsky T, Diaz-Arrastia R. Dissecting temporal profiles of neuronal and axonal damage after mild traumatic brain injury. JAMA Neurol. 2016 March 28 [Epub ahead of print].

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Polytrauma System of Care Reaches Milestone

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Through tools and resources, the VA’s Polytrauma System of Care reaches its million veteran milestone.

Since 2005, 1 million veterans have been screened for traumatic brain injury (TBI) in the VA’s Polytrauma System of Care (PSC).

The 1 million milestone “reflects [the] VA’s success in building an integrated polytrauma care program,” says VA Under Secretary for Health David Shulkin, MD. The PSC was created to address the need for a multidisciplinary system of care for veterans who have 2 or more disabling physical, cognitive, functional, or psychological impairments.

The VA has 110 polytrauma rehabilitation sites that offer comprehensive inpatient or outpatient rehabilitation. Services include interdisciplinary evaluation and treatment, development of a comprehensive plan of care, case management, patient and family education, psychosocial support, and use of advanced rehabilitation treatments and prosthetic technologies. 

Another tool that supports clinical TBI care is the mobile phone application, Concussion Coach. The app provides a self-assessment tool for measuring symptoms, including feedback and a symptom tracker; relaxation exercises and other coping tips; and immediate access to crisis resources, personal support contacts, or professional health care resources.

All veterans are screened for possible TBI with a 4-question test. Those with a positive screen are referred to a TBI specialist for a Comprehensive TBI Evaluation, but specialists are often located at VA medical centers that not all veterans can easily reach. Therefore, the Office of Health Care Transformation funded a project to develop a standardized Comprehensive TBI Evaluation protocol delivered via telehealth technology. In 2013, a pilot project began at 16 sites; more than 40 sites have since been trained.

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Through tools and resources, the VA’s Polytrauma System of Care reaches its million veteran milestone.
Through tools and resources, the VA’s Polytrauma System of Care reaches its million veteran milestone.

Since 2005, 1 million veterans have been screened for traumatic brain injury (TBI) in the VA’s Polytrauma System of Care (PSC).

The 1 million milestone “reflects [the] VA’s success in building an integrated polytrauma care program,” says VA Under Secretary for Health David Shulkin, MD. The PSC was created to address the need for a multidisciplinary system of care for veterans who have 2 or more disabling physical, cognitive, functional, or psychological impairments.

The VA has 110 polytrauma rehabilitation sites that offer comprehensive inpatient or outpatient rehabilitation. Services include interdisciplinary evaluation and treatment, development of a comprehensive plan of care, case management, patient and family education, psychosocial support, and use of advanced rehabilitation treatments and prosthetic technologies. 

Another tool that supports clinical TBI care is the mobile phone application, Concussion Coach. The app provides a self-assessment tool for measuring symptoms, including feedback and a symptom tracker; relaxation exercises and other coping tips; and immediate access to crisis resources, personal support contacts, or professional health care resources.

All veterans are screened for possible TBI with a 4-question test. Those with a positive screen are referred to a TBI specialist for a Comprehensive TBI Evaluation, but specialists are often located at VA medical centers that not all veterans can easily reach. Therefore, the Office of Health Care Transformation funded a project to develop a standardized Comprehensive TBI Evaluation protocol delivered via telehealth technology. In 2013, a pilot project began at 16 sites; more than 40 sites have since been trained.

Since 2005, 1 million veterans have been screened for traumatic brain injury (TBI) in the VA’s Polytrauma System of Care (PSC).

The 1 million milestone “reflects [the] VA’s success in building an integrated polytrauma care program,” says VA Under Secretary for Health David Shulkin, MD. The PSC was created to address the need for a multidisciplinary system of care for veterans who have 2 or more disabling physical, cognitive, functional, or psychological impairments.

The VA has 110 polytrauma rehabilitation sites that offer comprehensive inpatient or outpatient rehabilitation. Services include interdisciplinary evaluation and treatment, development of a comprehensive plan of care, case management, patient and family education, psychosocial support, and use of advanced rehabilitation treatments and prosthetic technologies. 

Another tool that supports clinical TBI care is the mobile phone application, Concussion Coach. The app provides a self-assessment tool for measuring symptoms, including feedback and a symptom tracker; relaxation exercises and other coping tips; and immediate access to crisis resources, personal support contacts, or professional health care resources.

All veterans are screened for possible TBI with a 4-question test. Those with a positive screen are referred to a TBI specialist for a Comprehensive TBI Evaluation, but specialists are often located at VA medical centers that not all veterans can easily reach. Therefore, the Office of Health Care Transformation funded a project to develop a standardized Comprehensive TBI Evaluation protocol delivered via telehealth technology. In 2013, a pilot project began at 16 sites; more than 40 sites have since been trained.

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Tool May Help Predict Persistent Postconcussion Symptoms

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A clinical risk score may help identify which children and adolescents with recent head injury are at risk for persistent postconcussion symptoms, according to an investigation published March 8 in JAMA.

Approximately one-third of pediatric patients with concussion have ongoing somatic, cognitive, psychological, or behavioral symptoms at 28 days. At present, neurologists have no tools to help predict which patients will be affected in this way. The 5P (Preventing Postconcussive Problems in Pediatrics) study was performed to develop and validate a clinical risk score for this purpose, said Roger Zemek, MD, a scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada, and his associates.

Roger Zemek, MD

This prospective cohort study involved patients between ages 5 and 17 (median age, 12) who presented to one of nine Canadian pediatric emergency departments within 48 hours of sustaining a concussion.

In the derivation cohort, 510 of 1,701 participants (30%) met the criteria for persistent postconcussion symptoms. The investigators assessed 47 possible predictive variables for their usefulness in predicting persistent postconcussion symptoms in this cohort. The variables were collected from demographic data, patient history, injury characteristics, physical examination, results on the Acute Concussion Evaluation Inventory and the Postconcussion Symptom Inventory, and patient and parent responses to weekly follow-up surveys during the month after the injury.

The investigators devised a clinical risk score using the following nine predictors that they found to be most accurate: age, gender, presence or absence of prior concussion, migraine history, presence or absence of current headache, sensitivity to noise, fatigue, slow responses to questions, and an abnormal tandem stance. They then selected three cutoff points to stratify the risk of persistent postconcussion symptoms: 0–3 points indicated low risk, 4–8 points indicated intermediate risk, and 9 or more points indicated high risk. Treating physicians also were asked to predict the likelihood of persistent postconcussion symptoms.

In the validation cohort, 291 of 883 participants (33%) met the criteria for persistent postconcussion symptoms. For low-risk patients, the sensitivity of the clinical risk score was 94%, the specificity was 18%, the negative predictive value was 85%, and the positive predictive value was 36%. For high-risk patients, the sensitivity of the clinical risk score was 20%, the specificity was 94%, the negative predictive value was 70%, and the positive predictive value was 60%.

In both sets of patients, the clinical risk score was significantly better than physician judgment in predicting persistent postconcussion symptoms. The clinical risk score has modest accuracy, however, at distinguishing between who will and who will not have persistent symptoms. This tool could be refined further, perhaps, by adding information regarding biomarkers, genetic susceptibility, or advanced neuroimaging, said Dr. Zemek and his associates.

Mary Ann Moon

References

Suggested Reading
Zemek R, Barrowman N, Freedman SB, et al. Clinical risk score for persistent postconcussion symptoms among children with acute concussion in the ED. JAMA. 2016;315(10):1014-1025.

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A clinical risk score may help identify which children and adolescents with recent head injury are at risk for persistent postconcussion symptoms, according to an investigation published March 8 in JAMA.

Approximately one-third of pediatric patients with concussion have ongoing somatic, cognitive, psychological, or behavioral symptoms at 28 days. At present, neurologists have no tools to help predict which patients will be affected in this way. The 5P (Preventing Postconcussive Problems in Pediatrics) study was performed to develop and validate a clinical risk score for this purpose, said Roger Zemek, MD, a scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada, and his associates.

Roger Zemek, MD

This prospective cohort study involved patients between ages 5 and 17 (median age, 12) who presented to one of nine Canadian pediatric emergency departments within 48 hours of sustaining a concussion.

In the derivation cohort, 510 of 1,701 participants (30%) met the criteria for persistent postconcussion symptoms. The investigators assessed 47 possible predictive variables for their usefulness in predicting persistent postconcussion symptoms in this cohort. The variables were collected from demographic data, patient history, injury characteristics, physical examination, results on the Acute Concussion Evaluation Inventory and the Postconcussion Symptom Inventory, and patient and parent responses to weekly follow-up surveys during the month after the injury.

The investigators devised a clinical risk score using the following nine predictors that they found to be most accurate: age, gender, presence or absence of prior concussion, migraine history, presence or absence of current headache, sensitivity to noise, fatigue, slow responses to questions, and an abnormal tandem stance. They then selected three cutoff points to stratify the risk of persistent postconcussion symptoms: 0–3 points indicated low risk, 4–8 points indicated intermediate risk, and 9 or more points indicated high risk. Treating physicians also were asked to predict the likelihood of persistent postconcussion symptoms.

In the validation cohort, 291 of 883 participants (33%) met the criteria for persistent postconcussion symptoms. For low-risk patients, the sensitivity of the clinical risk score was 94%, the specificity was 18%, the negative predictive value was 85%, and the positive predictive value was 36%. For high-risk patients, the sensitivity of the clinical risk score was 20%, the specificity was 94%, the negative predictive value was 70%, and the positive predictive value was 60%.

In both sets of patients, the clinical risk score was significantly better than physician judgment in predicting persistent postconcussion symptoms. The clinical risk score has modest accuracy, however, at distinguishing between who will and who will not have persistent symptoms. This tool could be refined further, perhaps, by adding information regarding biomarkers, genetic susceptibility, or advanced neuroimaging, said Dr. Zemek and his associates.

Mary Ann Moon

A clinical risk score may help identify which children and adolescents with recent head injury are at risk for persistent postconcussion symptoms, according to an investigation published March 8 in JAMA.

Approximately one-third of pediatric patients with concussion have ongoing somatic, cognitive, psychological, or behavioral symptoms at 28 days. At present, neurologists have no tools to help predict which patients will be affected in this way. The 5P (Preventing Postconcussive Problems in Pediatrics) study was performed to develop and validate a clinical risk score for this purpose, said Roger Zemek, MD, a scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada, and his associates.

Roger Zemek, MD

This prospective cohort study involved patients between ages 5 and 17 (median age, 12) who presented to one of nine Canadian pediatric emergency departments within 48 hours of sustaining a concussion.

In the derivation cohort, 510 of 1,701 participants (30%) met the criteria for persistent postconcussion symptoms. The investigators assessed 47 possible predictive variables for their usefulness in predicting persistent postconcussion symptoms in this cohort. The variables were collected from demographic data, patient history, injury characteristics, physical examination, results on the Acute Concussion Evaluation Inventory and the Postconcussion Symptom Inventory, and patient and parent responses to weekly follow-up surveys during the month after the injury.

The investigators devised a clinical risk score using the following nine predictors that they found to be most accurate: age, gender, presence or absence of prior concussion, migraine history, presence or absence of current headache, sensitivity to noise, fatigue, slow responses to questions, and an abnormal tandem stance. They then selected three cutoff points to stratify the risk of persistent postconcussion symptoms: 0–3 points indicated low risk, 4–8 points indicated intermediate risk, and 9 or more points indicated high risk. Treating physicians also were asked to predict the likelihood of persistent postconcussion symptoms.

In the validation cohort, 291 of 883 participants (33%) met the criteria for persistent postconcussion symptoms. For low-risk patients, the sensitivity of the clinical risk score was 94%, the specificity was 18%, the negative predictive value was 85%, and the positive predictive value was 36%. For high-risk patients, the sensitivity of the clinical risk score was 20%, the specificity was 94%, the negative predictive value was 70%, and the positive predictive value was 60%.

In both sets of patients, the clinical risk score was significantly better than physician judgment in predicting persistent postconcussion symptoms. The clinical risk score has modest accuracy, however, at distinguishing between who will and who will not have persistent symptoms. This tool could be refined further, perhaps, by adding information regarding biomarkers, genetic susceptibility, or advanced neuroimaging, said Dr. Zemek and his associates.

Mary Ann Moon

References

Suggested Reading
Zemek R, Barrowman N, Freedman SB, et al. Clinical risk score for persistent postconcussion symptoms among children with acute concussion in the ED. JAMA. 2016;315(10):1014-1025.

References

Suggested Reading
Zemek R, Barrowman N, Freedman SB, et al. Clinical risk score for persistent postconcussion symptoms among children with acute concussion in the ED. JAMA. 2016;315(10):1014-1025.

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Increase in Blood Pressure May Improve Survival in TBI

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SAN DIEGO—In the setting of traumatic brain injury (TBI), increases in systolic blood pressure after the blood pressure nadir are independently associated with improved survival in patients with hypotension. In addition, even substantial blood pressure increases do not seem to harm patients with normal blood pressure. These findings come from a subanalysis of the ongoing Excellence in Prehospital Injury Care (EPIC) TBI study.

“Little is known about the patterns of blood pressure in TBI in the field,” said Daniel W. Spaite, MD, Professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona in Tucson, at the Annual Meeting of the National Association of EMS Physicians (NAEMSP). “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”

Daniel W. Spaite, MD

Dr. Spaite and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in patients with major TBI who are part of the EPIC study, the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked, and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic blood pressure was between 40 and 300 mmHg.”

The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure after the lowest EMS blood pressure recorded and its association with adjusted probability of death. They then separated the study population into four cohorts, based on each patient’s prehospital systolic blood pressure (ie, 40–89 mmHg, 90–139 mmHg, 140–159 mmHg, and 160–300 mmHg). In each cohort, they identified the independent association between the magnitude of increase in systolic blood pressure and the adjusted probability of death.

Dr. Spaite reported findings from 14,567 patients with TBI. More than two-thirds (68%) of participants were male, and their mean age was 45. The researchers observed that in the hypotensive cohort, mortality dropped significantly if the systolic blood pressure increased after the lowest recorded systolic blood pressure. “Improvements were dramatic with increases of 40–80 mmHg,” he said. In the normotensive group, increases in systolic blood pressure were associated with slight reductions in mortality. Large increases in systolic blood pressure, such as in the range of 70–90 mmHg, did not appear to be detrimental.In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [systolic blood pressure] is between 140 and 159 mmHg, until you get above an increase of 40 mmHg above that, you don’t start seeing increases in mortality,” said Dr. Spaite. In the severely hypertensive group, mortality was higher with any subsequent increase in systolic blood pressure, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”

Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”

He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS TBI management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”

Doug Brunk

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SAN DIEGO—In the setting of traumatic brain injury (TBI), increases in systolic blood pressure after the blood pressure nadir are independently associated with improved survival in patients with hypotension. In addition, even substantial blood pressure increases do not seem to harm patients with normal blood pressure. These findings come from a subanalysis of the ongoing Excellence in Prehospital Injury Care (EPIC) TBI study.

“Little is known about the patterns of blood pressure in TBI in the field,” said Daniel W. Spaite, MD, Professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona in Tucson, at the Annual Meeting of the National Association of EMS Physicians (NAEMSP). “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”

Daniel W. Spaite, MD

Dr. Spaite and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in patients with major TBI who are part of the EPIC study, the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked, and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic blood pressure was between 40 and 300 mmHg.”

The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure after the lowest EMS blood pressure recorded and its association with adjusted probability of death. They then separated the study population into four cohorts, based on each patient’s prehospital systolic blood pressure (ie, 40–89 mmHg, 90–139 mmHg, 140–159 mmHg, and 160–300 mmHg). In each cohort, they identified the independent association between the magnitude of increase in systolic blood pressure and the adjusted probability of death.

Dr. Spaite reported findings from 14,567 patients with TBI. More than two-thirds (68%) of participants were male, and their mean age was 45. The researchers observed that in the hypotensive cohort, mortality dropped significantly if the systolic blood pressure increased after the lowest recorded systolic blood pressure. “Improvements were dramatic with increases of 40–80 mmHg,” he said. In the normotensive group, increases in systolic blood pressure were associated with slight reductions in mortality. Large increases in systolic blood pressure, such as in the range of 70–90 mmHg, did not appear to be detrimental.In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [systolic blood pressure] is between 140 and 159 mmHg, until you get above an increase of 40 mmHg above that, you don’t start seeing increases in mortality,” said Dr. Spaite. In the severely hypertensive group, mortality was higher with any subsequent increase in systolic blood pressure, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”

Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”

He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS TBI management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”

Doug Brunk

SAN DIEGO—In the setting of traumatic brain injury (TBI), increases in systolic blood pressure after the blood pressure nadir are independently associated with improved survival in patients with hypotension. In addition, even substantial blood pressure increases do not seem to harm patients with normal blood pressure. These findings come from a subanalysis of the ongoing Excellence in Prehospital Injury Care (EPIC) TBI study.

“Little is known about the patterns of blood pressure in TBI in the field,” said Daniel W. Spaite, MD, Professor and Virginia Piper Endowed Chair of Emergency Medicine at the University of Arizona in Tucson, at the Annual Meeting of the National Association of EMS Physicians (NAEMSP). “For instance, nobody knows whether it’s better to have your blood pressure increasing, stable, or decreasing in the field with regard to outcome, especially mortality. Typical studies that do have EMS data linked only have a single blood pressure measurement documented, so there’s no knowledge of trends in EMS blood pressure in TBI.”

Daniel W. Spaite, MD

Dr. Spaite and his colleagues evaluated the association between mortality and increases in prehospital systolic blood pressure after the lowest recorded measurement in patients with major TBI who are part of the EPIC study, the statewide implementation of TBI guidelines from the Brain Trauma Foundation and the NAEMSP. Data sources include the Arizona State Trauma Registry, which has comprehensive hospital outcome data. “The cases are then linked, and the EMS patient care reports are carefully abstracted by the EPIC data team,” Dr. Spaite explained. “This included major TBI (which is, clinically, both moderate and severe) and all patients whose lowest systolic blood pressure was between 40 and 300 mmHg.”

The researchers used logistic regression to examine the association between the increase in EMS systolic blood pressure after the lowest EMS blood pressure recorded and its association with adjusted probability of death. They then separated the study population into four cohorts, based on each patient’s prehospital systolic blood pressure (ie, 40–89 mmHg, 90–139 mmHg, 140–159 mmHg, and 160–300 mmHg). In each cohort, they identified the independent association between the magnitude of increase in systolic blood pressure and the adjusted probability of death.

Dr. Spaite reported findings from 14,567 patients with TBI. More than two-thirds (68%) of participants were male, and their mean age was 45. The researchers observed that in the hypotensive cohort, mortality dropped significantly if the systolic blood pressure increased after the lowest recorded systolic blood pressure. “Improvements were dramatic with increases of 40–80 mmHg,” he said. In the normotensive group, increases in systolic blood pressure were associated with slight reductions in mortality. Large increases in systolic blood pressure, such as in the range of 70–90 mmHg, did not appear to be detrimental.In the mildly hypertensive group, large systolic increases were associated with higher mortality. “Interestingly, even if your lowest [systolic blood pressure] is between 140 and 159 mmHg, until you get above an increase of 40 mmHg above that, you don’t start seeing increases in mortality,” said Dr. Spaite. In the severely hypertensive group, mortality was higher with any subsequent increase in systolic blood pressure, “which doesn’t surprise any of us,” he said. “It’s dramatically higher if the increase is large.”

Dr. Spaite emphasized that the current analysis is based on observational data, “so this does not prove that treating hypotension improves outcome. … That direct question is part of the EPIC study itself and awaits the final analysis, hopefully in mid-2017. This is the first large report of blood pressure trends in the prehospital management of TBI.”

He concluded that the current findings in the hypotensive and normotensive cohorts “support guideline recommendations for restoring and optimizing cerebral perfusion in EMS TBI management. What is fascinating about the literature is that the focus in TBI has always been on hypotension, but there’s very little information about what’s the best or the optimal blood pressure.”

Doug Brunk

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BRAIN Initiative Could Advance the Field of Neuromodulation

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BRAIN Initiative Could Advance the Field of Neuromodulation

LAS VEGAS—Through various programs, the BRAIN Initiative seeks to fund research in 2016 that could advance the field of neuromodulation, according to a lecture given at the 19th Annual Meeting of the North American Neuromodulation Society. These investigations could affect the treatment of epilepsy, headache, Parkinson’s disease, or other neurologic disorders.

The BRAIN Initiative has two main objectives, said Stephanie Fertig, MBA, Director of Small Business Programs at the National Institute of Neurological Disorders and Stroke. The first is to foster the development of new technologies for mapping connections in the brain and discovering patterns of neural activity. The second goal is to use these new technologies, as well as existing technologies, to further neurologists’ understanding of how the neural circuit affects the function of the healthy or diseased brain. The initiative, which President Obama introduced in 2013, is a collaboration between federal agencies, including the National Science Foundation and NIH, private foundations, universities, and industry. Information on the BRAIN Initiative can be found online at www.braininitiative.nih.gov.

Researchers Invited to Apply for Funding

Several of the BRAIN Initiative’s programs are intended to promote the identification, development, and optimization of new technologies and approaches for large-scale recording and modulation in the nervous system. The goal is to foster research that will add to scientific understanding of the dynamic signaling in the nervous system, said Ms. Fertig. One program seeks applications to study new and untested ideas for recording and modulating technology, including ideas in the initial stages of conceptualization. Other programs aim to further proof-of-concept testing for such technology, as well as to enable the optimization of the technology with feedback from the user community.

Another of the initiative’s programs is intended to fund nonclinical and clinical studies that will help advance invasive recording or stimulating devices that could, in turn, treat CNS disorders and improve understanding of the human brain. Researchers will receive support for the implementation of clinical prototype devices, nonclinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for a small clinical study. The program will consider clinical studies of acute or short-term procedures that entail nonsignificant risk (as determined by an Institutional Review Board), as well as those that entail a significant risk and require an Investigational Device Exemption (IDE) from the FDA. The BRAIN Initiative provides two options for researchers interested in funding for invasive devices, said Ms. Fertig. “One is if you need to do some nonclinical work before you get your IDE and then move into the clinic. That’s the phase translational to clinical research track. Then there’s the direct-to-clinical research program,” which is appropriate for investigators who do not need to perform nonclinical work and are ready for a clinical study.

Public–Private Partnership Program

The BRAIN Initiative also created a Public–Private Partnership Program to facilitate collaboration between clinical investigators and manufacturers of invasive recording or stimulating devices. This program is intended to promote clinical research and foster partnerships between clinical researchers and the developers of “next-generation implantable stimulating–recording devices,” said Ms. Fertig. Data about the safety and utility of such devices can be costly to obtain, but the Public–Private Partnership Program will enable researchers to use existing manufacturers’ safety data. To date, six device manufacturers (ie, Medtronic, Boston Scientific, Blackrock, NeuroPace, NeuroNexus, and Second Sight) have signed a memorandum of understanding with NIH to provide support and information on materials (eg, devices and software). The information will guide investigators who want to pursue specific agreements with manufacturers for the submission of research proposals to NIH. Furthermore, NIH has created templates of collaborative research agreements and confidential disclosure agreements to quicken the legal and administrative process for establishing partnerships between manufacturers and academic research institutions.

Funding Supports Device-Related Research

The BRAIN Initiative already has funded various studies that could lead to new invasive treatments for various neurologic disorders. Leigh R. Hochberg, MD, PhD, Director of the Neurotechnology Trials Unit at Massachusetts General Hospital in Boston, and associates received NIH support for the development of the BrainGate device. Dr. Hochberg created BrainGate, a brain implant system, to allow patients with quadriplegia to control external devices such as prosthetic arms by thought alone. Dr. Hochberg’s BRAIN project is to develop BrainGate into a fully implanted medical treatment system without external components. The goal is to enable patients to use the device independently on an ongoing basis.

In addition, Gregory A. Worrell, MD, PhD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and colleagues received funding to study wireless devices that measure brain activity, predict seizure onset, and deliver therapeutic stimulation to mitigate seizures. Dr. Worrell’s group initially plans to conduct a preclinical study to test one such device in dogs with epilepsy. If the device is successful, the group will perform a pilot clinical trial in patients with epilepsy.

 

 

Finally, Nicholas D. Schiff, MD, Jerold B. Katz Professor of Neurology and Neuroscience at Weill Cornell Medical College in New York, and colleagues received support for their efforts to develop device therapy for cognitive impairment associated with traumatic brain injury. They are focusing on a device that delivers deep brain stimulation to the thalamus, which they hypothesize may restore the disrupted circuit function that underlies the cognitive disability.

Erik Greb

References

Suggested Reading
Brinkmann BH, Patterson EE, Vite C, et al. Forecasting seizures using intracranial EEG measures and SVM in naturally occurring canine epilepsy. PLoS One. 2015;10(8):e0133900.
Gummadavelli A, Motelow JE, Smith N, et al. Thalamic stimulation to improve level of consciousness after seizures: evaluation of electrophysiology and behavior. Epilepsia. 2015;56(1):114-124.
Hochberg LR, Bacher D, Jarosiewicz B, et al. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012;485(7398):372-375.

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LAS VEGAS—Through various programs, the BRAIN Initiative seeks to fund research in 2016 that could advance the field of neuromodulation, according to a lecture given at the 19th Annual Meeting of the North American Neuromodulation Society. These investigations could affect the treatment of epilepsy, headache, Parkinson’s disease, or other neurologic disorders.

The BRAIN Initiative has two main objectives, said Stephanie Fertig, MBA, Director of Small Business Programs at the National Institute of Neurological Disorders and Stroke. The first is to foster the development of new technologies for mapping connections in the brain and discovering patterns of neural activity. The second goal is to use these new technologies, as well as existing technologies, to further neurologists’ understanding of how the neural circuit affects the function of the healthy or diseased brain. The initiative, which President Obama introduced in 2013, is a collaboration between federal agencies, including the National Science Foundation and NIH, private foundations, universities, and industry. Information on the BRAIN Initiative can be found online at www.braininitiative.nih.gov.

Researchers Invited to Apply for Funding

Several of the BRAIN Initiative’s programs are intended to promote the identification, development, and optimization of new technologies and approaches for large-scale recording and modulation in the nervous system. The goal is to foster research that will add to scientific understanding of the dynamic signaling in the nervous system, said Ms. Fertig. One program seeks applications to study new and untested ideas for recording and modulating technology, including ideas in the initial stages of conceptualization. Other programs aim to further proof-of-concept testing for such technology, as well as to enable the optimization of the technology with feedback from the user community.

Another of the initiative’s programs is intended to fund nonclinical and clinical studies that will help advance invasive recording or stimulating devices that could, in turn, treat CNS disorders and improve understanding of the human brain. Researchers will receive support for the implementation of clinical prototype devices, nonclinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for a small clinical study. The program will consider clinical studies of acute or short-term procedures that entail nonsignificant risk (as determined by an Institutional Review Board), as well as those that entail a significant risk and require an Investigational Device Exemption (IDE) from the FDA. The BRAIN Initiative provides two options for researchers interested in funding for invasive devices, said Ms. Fertig. “One is if you need to do some nonclinical work before you get your IDE and then move into the clinic. That’s the phase translational to clinical research track. Then there’s the direct-to-clinical research program,” which is appropriate for investigators who do not need to perform nonclinical work and are ready for a clinical study.

Public–Private Partnership Program

The BRAIN Initiative also created a Public–Private Partnership Program to facilitate collaboration between clinical investigators and manufacturers of invasive recording or stimulating devices. This program is intended to promote clinical research and foster partnerships between clinical researchers and the developers of “next-generation implantable stimulating–recording devices,” said Ms. Fertig. Data about the safety and utility of such devices can be costly to obtain, but the Public–Private Partnership Program will enable researchers to use existing manufacturers’ safety data. To date, six device manufacturers (ie, Medtronic, Boston Scientific, Blackrock, NeuroPace, NeuroNexus, and Second Sight) have signed a memorandum of understanding with NIH to provide support and information on materials (eg, devices and software). The information will guide investigators who want to pursue specific agreements with manufacturers for the submission of research proposals to NIH. Furthermore, NIH has created templates of collaborative research agreements and confidential disclosure agreements to quicken the legal and administrative process for establishing partnerships between manufacturers and academic research institutions.

Funding Supports Device-Related Research

The BRAIN Initiative already has funded various studies that could lead to new invasive treatments for various neurologic disorders. Leigh R. Hochberg, MD, PhD, Director of the Neurotechnology Trials Unit at Massachusetts General Hospital in Boston, and associates received NIH support for the development of the BrainGate device. Dr. Hochberg created BrainGate, a brain implant system, to allow patients with quadriplegia to control external devices such as prosthetic arms by thought alone. Dr. Hochberg’s BRAIN project is to develop BrainGate into a fully implanted medical treatment system without external components. The goal is to enable patients to use the device independently on an ongoing basis.

In addition, Gregory A. Worrell, MD, PhD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and colleagues received funding to study wireless devices that measure brain activity, predict seizure onset, and deliver therapeutic stimulation to mitigate seizures. Dr. Worrell’s group initially plans to conduct a preclinical study to test one such device in dogs with epilepsy. If the device is successful, the group will perform a pilot clinical trial in patients with epilepsy.

 

 

Finally, Nicholas D. Schiff, MD, Jerold B. Katz Professor of Neurology and Neuroscience at Weill Cornell Medical College in New York, and colleagues received support for their efforts to develop device therapy for cognitive impairment associated with traumatic brain injury. They are focusing on a device that delivers deep brain stimulation to the thalamus, which they hypothesize may restore the disrupted circuit function that underlies the cognitive disability.

Erik Greb

LAS VEGAS—Through various programs, the BRAIN Initiative seeks to fund research in 2016 that could advance the field of neuromodulation, according to a lecture given at the 19th Annual Meeting of the North American Neuromodulation Society. These investigations could affect the treatment of epilepsy, headache, Parkinson’s disease, or other neurologic disorders.

The BRAIN Initiative has two main objectives, said Stephanie Fertig, MBA, Director of Small Business Programs at the National Institute of Neurological Disorders and Stroke. The first is to foster the development of new technologies for mapping connections in the brain and discovering patterns of neural activity. The second goal is to use these new technologies, as well as existing technologies, to further neurologists’ understanding of how the neural circuit affects the function of the healthy or diseased brain. The initiative, which President Obama introduced in 2013, is a collaboration between federal agencies, including the National Science Foundation and NIH, private foundations, universities, and industry. Information on the BRAIN Initiative can be found online at www.braininitiative.nih.gov.

Researchers Invited to Apply for Funding

Several of the BRAIN Initiative’s programs are intended to promote the identification, development, and optimization of new technologies and approaches for large-scale recording and modulation in the nervous system. The goal is to foster research that will add to scientific understanding of the dynamic signaling in the nervous system, said Ms. Fertig. One program seeks applications to study new and untested ideas for recording and modulating technology, including ideas in the initial stages of conceptualization. Other programs aim to further proof-of-concept testing for such technology, as well as to enable the optimization of the technology with feedback from the user community.

Another of the initiative’s programs is intended to fund nonclinical and clinical studies that will help advance invasive recording or stimulating devices that could, in turn, treat CNS disorders and improve understanding of the human brain. Researchers will receive support for the implementation of clinical prototype devices, nonclinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for a small clinical study. The program will consider clinical studies of acute or short-term procedures that entail nonsignificant risk (as determined by an Institutional Review Board), as well as those that entail a significant risk and require an Investigational Device Exemption (IDE) from the FDA. The BRAIN Initiative provides two options for researchers interested in funding for invasive devices, said Ms. Fertig. “One is if you need to do some nonclinical work before you get your IDE and then move into the clinic. That’s the phase translational to clinical research track. Then there’s the direct-to-clinical research program,” which is appropriate for investigators who do not need to perform nonclinical work and are ready for a clinical study.

Public–Private Partnership Program

The BRAIN Initiative also created a Public–Private Partnership Program to facilitate collaboration between clinical investigators and manufacturers of invasive recording or stimulating devices. This program is intended to promote clinical research and foster partnerships between clinical researchers and the developers of “next-generation implantable stimulating–recording devices,” said Ms. Fertig. Data about the safety and utility of such devices can be costly to obtain, but the Public–Private Partnership Program will enable researchers to use existing manufacturers’ safety data. To date, six device manufacturers (ie, Medtronic, Boston Scientific, Blackrock, NeuroPace, NeuroNexus, and Second Sight) have signed a memorandum of understanding with NIH to provide support and information on materials (eg, devices and software). The information will guide investigators who want to pursue specific agreements with manufacturers for the submission of research proposals to NIH. Furthermore, NIH has created templates of collaborative research agreements and confidential disclosure agreements to quicken the legal and administrative process for establishing partnerships between manufacturers and academic research institutions.

Funding Supports Device-Related Research

The BRAIN Initiative already has funded various studies that could lead to new invasive treatments for various neurologic disorders. Leigh R. Hochberg, MD, PhD, Director of the Neurotechnology Trials Unit at Massachusetts General Hospital in Boston, and associates received NIH support for the development of the BrainGate device. Dr. Hochberg created BrainGate, a brain implant system, to allow patients with quadriplegia to control external devices such as prosthetic arms by thought alone. Dr. Hochberg’s BRAIN project is to develop BrainGate into a fully implanted medical treatment system without external components. The goal is to enable patients to use the device independently on an ongoing basis.

In addition, Gregory A. Worrell, MD, PhD, Professor of Neurology at Mayo Clinic in Rochester, Minnesota, and colleagues received funding to study wireless devices that measure brain activity, predict seizure onset, and deliver therapeutic stimulation to mitigate seizures. Dr. Worrell’s group initially plans to conduct a preclinical study to test one such device in dogs with epilepsy. If the device is successful, the group will perform a pilot clinical trial in patients with epilepsy.

 

 

Finally, Nicholas D. Schiff, MD, Jerold B. Katz Professor of Neurology and Neuroscience at Weill Cornell Medical College in New York, and colleagues received support for their efforts to develop device therapy for cognitive impairment associated with traumatic brain injury. They are focusing on a device that delivers deep brain stimulation to the thalamus, which they hypothesize may restore the disrupted circuit function that underlies the cognitive disability.

Erik Greb

References

Suggested Reading
Brinkmann BH, Patterson EE, Vite C, et al. Forecasting seizures using intracranial EEG measures and SVM in naturally occurring canine epilepsy. PLoS One. 2015;10(8):e0133900.
Gummadavelli A, Motelow JE, Smith N, et al. Thalamic stimulation to improve level of consciousness after seizures: evaluation of electrophysiology and behavior. Epilepsia. 2015;56(1):114-124.
Hochberg LR, Bacher D, Jarosiewicz B, et al. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012;485(7398):372-375.

References

Suggested Reading
Brinkmann BH, Patterson EE, Vite C, et al. Forecasting seizures using intracranial EEG measures and SVM in naturally occurring canine epilepsy. PLoS One. 2015;10(8):e0133900.
Gummadavelli A, Motelow JE, Smith N, et al. Thalamic stimulation to improve level of consciousness after seizures: evaluation of electrophysiology and behavior. Epilepsia. 2015;56(1):114-124.
Hochberg LR, Bacher D, Jarosiewicz B, et al. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012;485(7398):372-375.

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