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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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Amaal J. Starling, MD

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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

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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

References

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BRAIN Initiative Could Advance the Field of Neuromodulation

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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

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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Limiting Full-Contact Practice Reduces Football Concussions

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WASHINGTON, DC—Limiting the amount of full-contact tackling that occurs in high school football practice reduces the rate of sports-related concussions among the athletes, according to a prospective study.

“Something as simple as saying they can’t tackle all the time, limiting the amount of minutes each month, reduced the incidence,” said Timothy A. McGuine, PhD, Senior Scientist at the University of Wisconsin, Madison, at the American Academy of Pediatrics Annual Meeting.

“The majority of sports-related concussions sustained in high school football practice occurred during full-contact activities,” he said. “The rate of sports-related concussions sustained in high school football practice was more than twice as high in the two seasons prior to a rule change limiting the amount and duration of full-contact activities.”

Testing a Tackle-Limiting Rule

In their study, Dr. McGuine and his associates tested the effects of a tackle-limiting rule implemented in 2014 in a state interscholastic athletic association for all players in grades 9 through 12. The rule prohibited full-contact play during the first practice week, and full contact was defined as “drills or game situations that occur at game speed when full tackles are made at a competitive pace and players are taken to the ground.” The players engaged in full-contact play for as long as 75 minutes total during the second week of practice and for a maximum of 60 min/week for all subsequent weeks in the practice season. The rule did not apply to games.

For data on the two years before the rule change, 2,081 athletes with a mean age of 16 reported their concussion history in the 2012 season, which included 36 schools, and the 2013 season, which included 18 schools. In 2014, licensed athletic trainers recorded the incidence and severity of each sports-related concussion for the 945 players at 26 schools. During all three seasons, almost half the concussions (46%) occurred during tackling. Although the overall rate of concussions dropped from 1.57 per 1,000 athletic exposures in the combined 2012 and 2013 seasons to 1.28 per 1,000 athletic exposures in the 2014 season, the difference was not significant. During the 2012 and 2013 seasons combined, 206 players (9%) sustained 211 concussions, compared with 67 players (7%) with 70 concussions in 2014.

The difference in concussions occurring during practice, however, did differ significantly before and after the rule change. The rate of concussions during practice in 2014 was 0.33 concussions per 1,000 athletic exposures, compared with 0.76 concussions per 1,000 exposures in the 2012 and 2013 seasons. Twelve of 15 concussions in 2014 practices occurred during full-contact practices, a rate of 0.57 per 1,000 exposures, and 82 of 86 concussions in the 2012 and 2013 seasons occurred during full contact practices, a rate of 0.87 per 1,000 exposures.

The investigators observed no difference in concussion rate during the games following the rule change. The 2014 rate of concussions during games was 5.74 per 1,000 exposures, compared with 5.81 per 1,000 exposures in the combined 2012 and 2013 seasons. The severity of concussions sustained before and after the rule change also did not differ, and athletes’ years of football-playing experience had no effect on the concussion incidence in 2014.

To Tackle or Not to Tackle?

Despite the relationship between full-contact play and concussions, Dr. McGuine said that he would not support banning tackling from football.

“I think the benefits of the sport far outweigh the risks,” Dr. McGuine said. “Concussions particularly have transcended a sports issue and become a public health issue and have become political, and I’m very much against legislators, policy makers, [and] associations making blanket rules without the evidence to back those,” he said. “There are lingering long-term effects from all orthopedic injuries, but we’re focusing on concussions.”

Equipment modification is unlikely to make much difference in concussion rates either, said Dr. McGuine, whose previous study on football helmets found that the brand and model did not influence concussion risk. “Concussions are multifactorial,” he said. “We can’t just limit the amount of force transmitted to the brain and say we’re going to stop these injuries from occurring.”

One important strategy for reducing concussions is increasing parents’ and athletes’ awareness about multiple injuries and about ways to reduce the risk, Dr. McGuine said.

“Concussions are like any other injury [such as] ankle sprains, knee injuries and surgeries, [and] shoulder dislocations,” he said. “If you have one, you’re more susceptible to having another one, as opposed to somebody who never had that injury, so the problems are repeat injuries and lingering injuries.” Any of these injuries can have a lasting effect on a young athlete’s quality of life, Dr. McGuine added.

 

 

Another way to decrease the incidence of concussions is to enforce rules against leading, or lowering, athletes’ heads during tackling.

“A big issue now is penalizing players for leading with their head and face, but I think we need to be consistent there, too,” Dr. McGuine said. “We can’t penalize defensive players for lowering their helmet if we’re not going to penalize running backs and wide receivers.”

Tara Haelle

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WASHINGTON, DC—Limiting the amount of full-contact tackling that occurs in high school football practice reduces the rate of sports-related concussions among the athletes, according to a prospective study.

“Something as simple as saying they can’t tackle all the time, limiting the amount of minutes each month, reduced the incidence,” said Timothy A. McGuine, PhD, Senior Scientist at the University of Wisconsin, Madison, at the American Academy of Pediatrics Annual Meeting.

“The majority of sports-related concussions sustained in high school football practice occurred during full-contact activities,” he said. “The rate of sports-related concussions sustained in high school football practice was more than twice as high in the two seasons prior to a rule change limiting the amount and duration of full-contact activities.”

Testing a Tackle-Limiting Rule

In their study, Dr. McGuine and his associates tested the effects of a tackle-limiting rule implemented in 2014 in a state interscholastic athletic association for all players in grades 9 through 12. The rule prohibited full-contact play during the first practice week, and full contact was defined as “drills or game situations that occur at game speed when full tackles are made at a competitive pace and players are taken to the ground.” The players engaged in full-contact play for as long as 75 minutes total during the second week of practice and for a maximum of 60 min/week for all subsequent weeks in the practice season. The rule did not apply to games.

For data on the two years before the rule change, 2,081 athletes with a mean age of 16 reported their concussion history in the 2012 season, which included 36 schools, and the 2013 season, which included 18 schools. In 2014, licensed athletic trainers recorded the incidence and severity of each sports-related concussion for the 945 players at 26 schools. During all three seasons, almost half the concussions (46%) occurred during tackling. Although the overall rate of concussions dropped from 1.57 per 1,000 athletic exposures in the combined 2012 and 2013 seasons to 1.28 per 1,000 athletic exposures in the 2014 season, the difference was not significant. During the 2012 and 2013 seasons combined, 206 players (9%) sustained 211 concussions, compared with 67 players (7%) with 70 concussions in 2014.

The difference in concussions occurring during practice, however, did differ significantly before and after the rule change. The rate of concussions during practice in 2014 was 0.33 concussions per 1,000 athletic exposures, compared with 0.76 concussions per 1,000 exposures in the 2012 and 2013 seasons. Twelve of 15 concussions in 2014 practices occurred during full-contact practices, a rate of 0.57 per 1,000 exposures, and 82 of 86 concussions in the 2012 and 2013 seasons occurred during full contact practices, a rate of 0.87 per 1,000 exposures.

The investigators observed no difference in concussion rate during the games following the rule change. The 2014 rate of concussions during games was 5.74 per 1,000 exposures, compared with 5.81 per 1,000 exposures in the combined 2012 and 2013 seasons. The severity of concussions sustained before and after the rule change also did not differ, and athletes’ years of football-playing experience had no effect on the concussion incidence in 2014.

To Tackle or Not to Tackle?

Despite the relationship between full-contact play and concussions, Dr. McGuine said that he would not support banning tackling from football.

“I think the benefits of the sport far outweigh the risks,” Dr. McGuine said. “Concussions particularly have transcended a sports issue and become a public health issue and have become political, and I’m very much against legislators, policy makers, [and] associations making blanket rules without the evidence to back those,” he said. “There are lingering long-term effects from all orthopedic injuries, but we’re focusing on concussions.”

Equipment modification is unlikely to make much difference in concussion rates either, said Dr. McGuine, whose previous study on football helmets found that the brand and model did not influence concussion risk. “Concussions are multifactorial,” he said. “We can’t just limit the amount of force transmitted to the brain and say we’re going to stop these injuries from occurring.”

One important strategy for reducing concussions is increasing parents’ and athletes’ awareness about multiple injuries and about ways to reduce the risk, Dr. McGuine said.

“Concussions are like any other injury [such as] ankle sprains, knee injuries and surgeries, [and] shoulder dislocations,” he said. “If you have one, you’re more susceptible to having another one, as opposed to somebody who never had that injury, so the problems are repeat injuries and lingering injuries.” Any of these injuries can have a lasting effect on a young athlete’s quality of life, Dr. McGuine added.

 

 

Another way to decrease the incidence of concussions is to enforce rules against leading, or lowering, athletes’ heads during tackling.

“A big issue now is penalizing players for leading with their head and face, but I think we need to be consistent there, too,” Dr. McGuine said. “We can’t penalize defensive players for lowering their helmet if we’re not going to penalize running backs and wide receivers.”

Tara Haelle

WASHINGTON, DC—Limiting the amount of full-contact tackling that occurs in high school football practice reduces the rate of sports-related concussions among the athletes, according to a prospective study.

“Something as simple as saying they can’t tackle all the time, limiting the amount of minutes each month, reduced the incidence,” said Timothy A. McGuine, PhD, Senior Scientist at the University of Wisconsin, Madison, at the American Academy of Pediatrics Annual Meeting.

“The majority of sports-related concussions sustained in high school football practice occurred during full-contact activities,” he said. “The rate of sports-related concussions sustained in high school football practice was more than twice as high in the two seasons prior to a rule change limiting the amount and duration of full-contact activities.”

Testing a Tackle-Limiting Rule

In their study, Dr. McGuine and his associates tested the effects of a tackle-limiting rule implemented in 2014 in a state interscholastic athletic association for all players in grades 9 through 12. The rule prohibited full-contact play during the first practice week, and full contact was defined as “drills or game situations that occur at game speed when full tackles are made at a competitive pace and players are taken to the ground.” The players engaged in full-contact play for as long as 75 minutes total during the second week of practice and for a maximum of 60 min/week for all subsequent weeks in the practice season. The rule did not apply to games.

For data on the two years before the rule change, 2,081 athletes with a mean age of 16 reported their concussion history in the 2012 season, which included 36 schools, and the 2013 season, which included 18 schools. In 2014, licensed athletic trainers recorded the incidence and severity of each sports-related concussion for the 945 players at 26 schools. During all three seasons, almost half the concussions (46%) occurred during tackling. Although the overall rate of concussions dropped from 1.57 per 1,000 athletic exposures in the combined 2012 and 2013 seasons to 1.28 per 1,000 athletic exposures in the 2014 season, the difference was not significant. During the 2012 and 2013 seasons combined, 206 players (9%) sustained 211 concussions, compared with 67 players (7%) with 70 concussions in 2014.

The difference in concussions occurring during practice, however, did differ significantly before and after the rule change. The rate of concussions during practice in 2014 was 0.33 concussions per 1,000 athletic exposures, compared with 0.76 concussions per 1,000 exposures in the 2012 and 2013 seasons. Twelve of 15 concussions in 2014 practices occurred during full-contact practices, a rate of 0.57 per 1,000 exposures, and 82 of 86 concussions in the 2012 and 2013 seasons occurred during full contact practices, a rate of 0.87 per 1,000 exposures.

The investigators observed no difference in concussion rate during the games following the rule change. The 2014 rate of concussions during games was 5.74 per 1,000 exposures, compared with 5.81 per 1,000 exposures in the combined 2012 and 2013 seasons. The severity of concussions sustained before and after the rule change also did not differ, and athletes’ years of football-playing experience had no effect on the concussion incidence in 2014.

To Tackle or Not to Tackle?

Despite the relationship between full-contact play and concussions, Dr. McGuine said that he would not support banning tackling from football.

“I think the benefits of the sport far outweigh the risks,” Dr. McGuine said. “Concussions particularly have transcended a sports issue and become a public health issue and have become political, and I’m very much against legislators, policy makers, [and] associations making blanket rules without the evidence to back those,” he said. “There are lingering long-term effects from all orthopedic injuries, but we’re focusing on concussions.”

Equipment modification is unlikely to make much difference in concussion rates either, said Dr. McGuine, whose previous study on football helmets found that the brand and model did not influence concussion risk. “Concussions are multifactorial,” he said. “We can’t just limit the amount of force transmitted to the brain and say we’re going to stop these injuries from occurring.”

One important strategy for reducing concussions is increasing parents’ and athletes’ awareness about multiple injuries and about ways to reduce the risk, Dr. McGuine said.

“Concussions are like any other injury [such as] ankle sprains, knee injuries and surgeries, [and] shoulder dislocations,” he said. “If you have one, you’re more susceptible to having another one, as opposed to somebody who never had that injury, so the problems are repeat injuries and lingering injuries.” Any of these injuries can have a lasting effect on a young athlete’s quality of life, Dr. McGuine added.

 

 

Another way to decrease the incidence of concussions is to enforce rules against leading, or lowering, athletes’ heads during tackling.

“A big issue now is penalizing players for leading with their head and face, but I think we need to be consistent there, too,” Dr. McGuine said. “We can’t penalize defensive players for lowering their helmet if we’re not going to penalize running backs and wide receivers.”

Tara Haelle

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