title: Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study.
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.
authors.affiliation: Headache Group-Department of Neurology, University of California, San Francisco, CA, USA Headache Group, NIHR-Wellcome Clinical Research Facility, King's College London, UK peter.goadsby@kcl.ac.uk.
authors.forename: P J
authors.initials: PJ
authors.lastname: Goadsby
authors.affiliation: Montefiore Headache Center, Bronx, NY, USA.
authors.forename: B M
authors.initials: BM
authors.lastname: Grosberg
authors.affiliation: New York Headache Center, New York, NY, USA.
authors.forename: A
authors.initials: A
authors.lastname: Mauskop
authors.affiliation: Clinvest, Headache Care Center, Springfield, MO, USA.
authors.forename: R
authors.initials: R
authors.lastname: Cady
authors.affiliation: electroCore LLC, Basking Ridge, NJ, USA.
authors.forename: K A
authors.initials: KA
authors.lastname: Simmons
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000628:therapy*; D010865:Pilot Projects; D055536:Vagus Nerve Stimulation
keywords: Migraine; acute treatment; neuromodulation; vagus nerve