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LOS ANGELES—Noninvasive vagus nerve stimulation (nVNS) is a rapidly effective, well-tolerated, and practical option for the acute treatment of episodic migraine, according to the results of PRESTO, a multicenter, randomized, sham-controlled, double-blind trial presented at the 70th Annual Meeting of the American Academy of Neurology. “There are multiple options for nVNS in the acute treatment of migraine,” said Cristina Tassorelli, MD, PhD, Professor of Neurology at the University of Pavia and Director of the Headache Science Centre at the Casimiro Mondino National Neurological Institute of Pavia in Italy. “It can be used alone because it is effective, it can be used in combination with drugs because we do not expect any significant interactions, and it is also indicated in patients who have developed medication overuse.”
Neuromodulation for Migraine
The aim of the PRESTO trial was to evaluate the efficacy, safety, and tolerability of gammaCore, an nVNS device, for the acute treatment of migraine. The handheld gammaCore device is already FDA cleared for the acute treatment of pain associated with episodic cluster headache and migraine headache in adults. PRESTO was the trial that supported the FDA clearance of gammaCore for migraine.
Following an observational period of four weeks, patients enrolled in PRESTO were randomized to nVNS or sham stimulation for four weeks or until five attacks were treated. Following this period, patients entered the open-label period for another four weeks or five additional attacks.
Low-intensity current, which induced a tingling sensation on the skin that was similar to the sensation of the active stimulation, was used for the sham stimulation. Patients were instructed to treat their attack early with two two-minute stimulations, one for each side of the neck. At 15 minutes, patients assessed the intensity of their pain. If pain was still present, another set of two stimulations was self-administered. A second assessment of pain occurred at 120 minutes, with the possibility of administering another stimulation. Rescue medication use before 120 minutes was considered to indicate treatment failure.
Patients with episodic migraine with or without aura were recruited from 10 Italian tertiary headache centers. A total of 285 patients were enrolled, and 248 randomized: 122 to the active arm and 126 to the sham arm. A total of 117 patients completed the double-blind period in the active arm, and 123 patients in the sham arm. “We had a few discontinuations in both arms, one of which was due to the device,” Dr. Tassorelli and colleagues noted. “Demographic and baseline characteristics show typical pictures of patients with episodic migraine,” Dr. Tassorelli said. Study subjects were mostly young, mostly female, and mostly experiencing migraine without aura. Subjects had a mean of five attacks of migraine per month, a mean of six days of headache per month, and a mean monthly intake of five acute migraine medications. One-third of the patients were on stable prophylactic medications. About 40% of the patients were having moderate pain when they treated their first attack. One-third of them were experiencing mild pain, while 23% were experiencing severe pain in the active group and 15% were having severe pain in the sham group.
Stimulation Reduced Pain
The primary end point of the study was pain freedom at 120 minutes for the first attack. The investigators found a significant difference between the two arms at 30 minutes that became more evident at 60 minutes. At 120 minutes, there was a difference, “but we lost the statistical significance,” Dr. Tassorelli reported. “However, a more refined, post hoc repeated-measure analysis showed that the group treated with the active stimulation had significantly more pain relief than the sham stimulation over the 120-minute period.”
One of the secondary outcome measures was headache
The rate of participants who had a therapeutic response for 50% of attacks or more at 120 minutes speaks to the consistency of the response. Almost half of the patients responded to nVNS at 120 minutes for 50% or more of all treated attacks—47.6% achieved mild or no pain at 120 minutes in the treatment group versus 32.3% in the sham group; 32.4% achieved pain freedom at 120 minutes in the treatment group versus 18.2% in the sham group.
“We did not have many adverse events in this study,” Dr. Tassorelli said. Adverse effects of nVNS, mainly application site discomfort, were infrequent, mild, and transitory. No serious adverse events were recorded, and none of the patients in the active treatment group discontinued treatment due to adverse events.
In summary, nVNS “proved superior to sham for pain freedom at 30 minutes and at 60 minutes, but not at 120 minutes, which was our primary end point,” said Dr. Tassorelli and colleagues. “However, repeated-measures analysis validated the primary end point, indicating the superiority of active stimulation over sham through 120 minutes. This study provides class one evidence for the efficacy of nVNS in the acute treatment of episodic migraine.”
This study was sponsored by electroCore.
—Glenn S. Williams
LOS ANGELES—Noninvasive vagus nerve stimulation (nVNS) is a rapidly effective, well-tolerated, and practical option for the acute treatment of episodic migraine, according to the results of PRESTO, a multicenter, randomized, sham-controlled, double-blind trial presented at the 70th Annual Meeting of the American Academy of Neurology. “There are multiple options for nVNS in the acute treatment of migraine,” said Cristina Tassorelli, MD, PhD, Professor of Neurology at the University of Pavia and Director of the Headache Science Centre at the Casimiro Mondino National Neurological Institute of Pavia in Italy. “It can be used alone because it is effective, it can be used in combination with drugs because we do not expect any significant interactions, and it is also indicated in patients who have developed medication overuse.”
Neuromodulation for Migraine
The aim of the PRESTO trial was to evaluate the efficacy, safety, and tolerability of gammaCore, an nVNS device, for the acute treatment of migraine. The handheld gammaCore device is already FDA cleared for the acute treatment of pain associated with episodic cluster headache and migraine headache in adults. PRESTO was the trial that supported the FDA clearance of gammaCore for migraine.
Following an observational period of four weeks, patients enrolled in PRESTO were randomized to nVNS or sham stimulation for four weeks or until five attacks were treated. Following this period, patients entered the open-label period for another four weeks or five additional attacks.
Low-intensity current, which induced a tingling sensation on the skin that was similar to the sensation of the active stimulation, was used for the sham stimulation. Patients were instructed to treat their attack early with two two-minute stimulations, one for each side of the neck. At 15 minutes, patients assessed the intensity of their pain. If pain was still present, another set of two stimulations was self-administered. A second assessment of pain occurred at 120 minutes, with the possibility of administering another stimulation. Rescue medication use before 120 minutes was considered to indicate treatment failure.
Patients with episodic migraine with or without aura were recruited from 10 Italian tertiary headache centers. A total of 285 patients were enrolled, and 248 randomized: 122 to the active arm and 126 to the sham arm. A total of 117 patients completed the double-blind period in the active arm, and 123 patients in the sham arm. “We had a few discontinuations in both arms, one of which was due to the device,” Dr. Tassorelli and colleagues noted. “Demographic and baseline characteristics show typical pictures of patients with episodic migraine,” Dr. Tassorelli said. Study subjects were mostly young, mostly female, and mostly experiencing migraine without aura. Subjects had a mean of five attacks of migraine per month, a mean of six days of headache per month, and a mean monthly intake of five acute migraine medications. One-third of the patients were on stable prophylactic medications. About 40% of the patients were having moderate pain when they treated their first attack. One-third of them were experiencing mild pain, while 23% were experiencing severe pain in the active group and 15% were having severe pain in the sham group.
Stimulation Reduced Pain
The primary end point of the study was pain freedom at 120 minutes for the first attack. The investigators found a significant difference between the two arms at 30 minutes that became more evident at 60 minutes. At 120 minutes, there was a difference, “but we lost the statistical significance,” Dr. Tassorelli reported. “However, a more refined, post hoc repeated-measure analysis showed that the group treated with the active stimulation had significantly more pain relief than the sham stimulation over the 120-minute period.”
One of the secondary outcome measures was headache
The rate of participants who had a therapeutic response for 50% of attacks or more at 120 minutes speaks to the consistency of the response. Almost half of the patients responded to nVNS at 120 minutes for 50% or more of all treated attacks—47.6% achieved mild or no pain at 120 minutes in the treatment group versus 32.3% in the sham group; 32.4% achieved pain freedom at 120 minutes in the treatment group versus 18.2% in the sham group.
“We did not have many adverse events in this study,” Dr. Tassorelli said. Adverse effects of nVNS, mainly application site discomfort, were infrequent, mild, and transitory. No serious adverse events were recorded, and none of the patients in the active treatment group discontinued treatment due to adverse events.
In summary, nVNS “proved superior to sham for pain freedom at 30 minutes and at 60 minutes, but not at 120 minutes, which was our primary end point,” said Dr. Tassorelli and colleagues. “However, repeated-measures analysis validated the primary end point, indicating the superiority of active stimulation over sham through 120 minutes. This study provides class one evidence for the efficacy of nVNS in the acute treatment of episodic migraine.”
This study was sponsored by electroCore.
—Glenn S. Williams
LOS ANGELES—Noninvasive vagus nerve stimulation (nVNS) is a rapidly effective, well-tolerated, and practical option for the acute treatment of episodic migraine, according to the results of PRESTO, a multicenter, randomized, sham-controlled, double-blind trial presented at the 70th Annual Meeting of the American Academy of Neurology. “There are multiple options for nVNS in the acute treatment of migraine,” said Cristina Tassorelli, MD, PhD, Professor of Neurology at the University of Pavia and Director of the Headache Science Centre at the Casimiro Mondino National Neurological Institute of Pavia in Italy. “It can be used alone because it is effective, it can be used in combination with drugs because we do not expect any significant interactions, and it is also indicated in patients who have developed medication overuse.”
Neuromodulation for Migraine
The aim of the PRESTO trial was to evaluate the efficacy, safety, and tolerability of gammaCore, an nVNS device, for the acute treatment of migraine. The handheld gammaCore device is already FDA cleared for the acute treatment of pain associated with episodic cluster headache and migraine headache in adults. PRESTO was the trial that supported the FDA clearance of gammaCore for migraine.
Following an observational period of four weeks, patients enrolled in PRESTO were randomized to nVNS or sham stimulation for four weeks or until five attacks were treated. Following this period, patients entered the open-label period for another four weeks or five additional attacks.
Low-intensity current, which induced a tingling sensation on the skin that was similar to the sensation of the active stimulation, was used for the sham stimulation. Patients were instructed to treat their attack early with two two-minute stimulations, one for each side of the neck. At 15 minutes, patients assessed the intensity of their pain. If pain was still present, another set of two stimulations was self-administered. A second assessment of pain occurred at 120 minutes, with the possibility of administering another stimulation. Rescue medication use before 120 minutes was considered to indicate treatment failure.
Patients with episodic migraine with or without aura were recruited from 10 Italian tertiary headache centers. A total of 285 patients were enrolled, and 248 randomized: 122 to the active arm and 126 to the sham arm. A total of 117 patients completed the double-blind period in the active arm, and 123 patients in the sham arm. “We had a few discontinuations in both arms, one of which was due to the device,” Dr. Tassorelli and colleagues noted. “Demographic and baseline characteristics show typical pictures of patients with episodic migraine,” Dr. Tassorelli said. Study subjects were mostly young, mostly female, and mostly experiencing migraine without aura. Subjects had a mean of five attacks of migraine per month, a mean of six days of headache per month, and a mean monthly intake of five acute migraine medications. One-third of the patients were on stable prophylactic medications. About 40% of the patients were having moderate pain when they treated their first attack. One-third of them were experiencing mild pain, while 23% were experiencing severe pain in the active group and 15% were having severe pain in the sham group.
Stimulation Reduced Pain
The primary end point of the study was pain freedom at 120 minutes for the first attack. The investigators found a significant difference between the two arms at 30 minutes that became more evident at 60 minutes. At 120 minutes, there was a difference, “but we lost the statistical significance,” Dr. Tassorelli reported. “However, a more refined, post hoc repeated-measure analysis showed that the group treated with the active stimulation had significantly more pain relief than the sham stimulation over the 120-minute period.”
One of the secondary outcome measures was headache
The rate of participants who had a therapeutic response for 50% of attacks or more at 120 minutes speaks to the consistency of the response. Almost half of the patients responded to nVNS at 120 minutes for 50% or more of all treated attacks—47.6% achieved mild or no pain at 120 minutes in the treatment group versus 32.3% in the sham group; 32.4% achieved pain freedom at 120 minutes in the treatment group versus 18.2% in the sham group.
“We did not have many adverse events in this study,” Dr. Tassorelli said. Adverse effects of nVNS, mainly application site discomfort, were infrequent, mild, and transitory. No serious adverse events were recorded, and none of the patients in the active treatment group discontinued treatment due to adverse events.
In summary, nVNS “proved superior to sham for pain freedom at 30 minutes and at 60 minutes, but not at 120 minutes, which was our primary end point,” said Dr. Tassorelli and colleagues. “However, repeated-measures analysis validated the primary end point, indicating the superiority of active stimulation over sham through 120 minutes. This study provides class one evidence for the efficacy of nVNS in the acute treatment of episodic migraine.”
This study was sponsored by electroCore.
—Glenn S. Williams