Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study

P. J. Goadsby, B. M. Grosberg, A. Mauskop, R. Cady, K. A. Simmons

Research output: Contribution to journalArticle

103 Scopus citations

Abstract

Background: We sought to assess a novel, noninvasive, portable vagal nerve stimulator (nVNS) for acute treatment of migraine

Methods: Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain.

Results: Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n= 1), raspy voice (n= 1) and redness at the device site (n= 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%).

Conclusions: nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients.

Original languageEnglish (US)
Pages (from-to)986-993
Number of pages8
JournalCephalalgia
Volume34
Issue number12
DOIs
StatePublished - Oct 27 2014

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Keywords

  • Migraine
  • acute treatment
  • neuromodulation
  • vagus nerve

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Goadsby, P. J., Grosberg, B. M., Mauskop, A., Cady, R., & Simmons, K. A. (2014). Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study. Cephalalgia, 34(12), 986-993. https://doi.org/10.1177/0333102414524494