Chronic migraine headache prevention with noninvasive vagus nerve stimulation

The EVENT study

the EVENT Study Group

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n 30) and sham treatment (n 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ 1.2; p 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Conclusions: Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. ClinicalTrials.gov identifier: NCT01667250. Classification of evidence: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.

Original languageEnglish (US)
Pages (from-to)529-538
Number of pages10
JournalNeurology
Volume87
Issue number5
DOIs
StatePublished - Aug 2 2016

Fingerprint

Vagus Nerve Stimulation
Headache Disorders
Migraine Disorders
Headache
Safety
Placebos
Therapeutics
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)
  • Clinical Neurology

Cite this

Chronic migraine headache prevention with noninvasive vagus nerve stimulation : The EVENT study. / the EVENT Study Group.

In: Neurology, Vol. 87, No. 5, 02.08.2016, p. 529-538.

Research output: Contribution to journalArticle

@article{5847eb96421d4ee1a652181227f3f38c,
title = "Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study",
abstract = "Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n 30) and sham treatment (n 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ 1.2; p 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95{\%} confidence interval -11.9 to -3.8; p < 0.01). Conclusions: Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. ClinicalTrials.gov identifier: NCT01667250. Classification of evidence: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.",
author = "{the EVENT Study Group} and Silberstein, {Stephen D.} and Calhoun, {Anne H.} and Lipton, {Richard B.} and Grosberg, {Brian M.} and Cady, {Roger K.} and Stefanie Dorlas and Simmons, {Kristy A.} and Chris Mullin and Liebler, {Eric J.} and Goadsby, {Peter J.} and Saper, {Joel R.}",
year = "2016",
month = "8",
day = "2",
doi = "10.1212/WNL.0000000000002918",
language = "English (US)",
volume = "87",
pages = "529--538",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Chronic migraine headache prevention with noninvasive vagus nerve stimulation

T2 - The EVENT study

AU - the EVENT Study Group

AU - Silberstein, Stephen D.

AU - Calhoun, Anne H.

AU - Lipton, Richard B.

AU - Grosberg, Brian M.

AU - Cady, Roger K.

AU - Dorlas, Stefanie

AU - Simmons, Kristy A.

AU - Mullin, Chris

AU - Liebler, Eric J.

AU - Goadsby, Peter J.

AU - Saper, Joel R.

PY - 2016/8/2

Y1 - 2016/8/2

N2 - Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n 30) and sham treatment (n 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ 1.2; p 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Conclusions: Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. ClinicalTrials.gov identifier: NCT01667250. Classification of evidence: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.

AB - Objective: To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. Methods: In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Results: Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n 30) and sham treatment (n 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ 1.2; p 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Conclusions: Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. ClinicalTrials.gov identifier: NCT01667250. Classification of evidence: This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.

UR - http://www.scopus.com/inward/record.url?scp=84982943004&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84982943004&partnerID=8YFLogxK

U2 - 10.1212/WNL.0000000000002918

DO - 10.1212/WNL.0000000000002918

M3 - Article

VL - 87

SP - 529

EP - 538

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 5

ER -