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

Clinical study in international headache journal finds electroCore’s non invasive vagus nerve stimulation effective in treating migraine

Clinical study in international headache journal finds electroCore’s non invasive vagus nerve stimulation effective in treating migraine

 

BusinessWire · Mar. 13, 2014 | Last Updated: Mar. 13, 2014 10:54 AM ET

A study reported (13^TH March 2014) in the International Headache Society’s official journal Cephalalgia found that the use of electroCore’s non invasive vagus nerve stimulation therapy (nVNS) may be an effective and well tolerated treatment for migraine in certain patients.

The open label study, which was led by Professor Goadsby, was carried out by the University of California, San Francisco and at four other sites in the US involving 30 patients.

Of the 30 enrolled patients 27 used the nVNS therapy to treat a total of 80 migraine attacks. Patients with moderate or severe headache attacks reported pain freedom or relief in, twenty-three out of fifty-four attacks (43 %). This included twelve out of fifty-four attacks where the patients reported being pain free at two hours after treatment (22 %). Additionally, in ten of twenty-six attacks when the patient treated while the pain was mild the patients reported being pain free at two hours (38 %). No unanticipated, serious or severe adverse events were reported and the paper stated that nVNS seems much better tolerated than the more potent triptans and does not have comparable cardiovascular or cerebrovascular concerns.

The study also found that certain patients responded positively on a consistent basis. Of eighteen patients who treated at least three attacks six were pain free on 2/3 occasions (33 %).

JP Errico CEO and founder of electroCore commented. “We are delighted to see that this easy to use treatment was found to be effective in a substantial number of patients for this debilitating and painful condition. The authors of this report noted the need for further placebo controlled trials and we are presently carrying out four double blind randomized controlled studies in the US and Europe which will read out in the second half of this year”

ElectroCore's proprietary, non invasive electrical stimulation therapy works by activating specific fibers in the vagus nerve bundle. This activation causes the release of inhibitory neurotransmitters within the central nervous system, and reduces the over expression of the excitatory neurotransmitter glutamate, which has been implicated in a number of different disorders.

Patients self treat by holding the device on their neck over the vagus nerve for two minutes. All patients are trained in the use of the device to ensure they place it correctly and they use the appropriate setting.

The great benefit of this therapy is that it is very safe. Surgically implanted VNS has been in use for more than 20 years in over a 100,000 patients without any side effects. It can also be used in conjunction with other medications as the chemicals it produces are endogenous and contained within the central nervous system.

Authors; J. Goadsby, B. M. Grosberg, A. Mauskop, R. Cadyand K.A. Simmons

Contacts

Vane Percy & Roberts for ElectroCore
Simon Vane Percy
+44-(0)-1737-821890
simon@vanepercy.com

http://www.nationalpost.com/markets/news/Clinical+study+international+headache+journal+finds+electroCore+invasive/9613205/story.html