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

Cephalalgia. 2014 Mar 7. [Epub ahead of print]

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

Goadsby P¹, Grosberg B, Mauskop A, Cady R, Simmons K.

Author information

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.

KEYWORDS:

Migraine, acute treatment, neuromodulation, vagus nerve

PMID:

24607501

[PubMed - as supplied by publisher] http://www.ncbi.nlm.nih.gov/pubmed/24607501