[S40.004] Non-Invasive Vagus Nerve Stimulation (nVNS) for Acute Treatment of Migraine: An Open-Label Pilot Study
Peter Goadsby, San Francisco, CA, Richard Lipton, Bronx, NY, Roger Cady, Springfield, MO, Alexander Mauskop, New York, NY, Brian Grosberg, Bronx, NY
OBJECTIVE: Assessment of a novel, non-invasive, portable VNS device for acute treatment of migraine. BACKGROUND: Despite many acute treatment options for migraine, substantial unmet need remains. VNS is promising, but relatively unexplored. DESIGN/METHODS: Participants with migraine with or without aura, as defined by the International Classification of Headache Disorders- second edition, were eligible for an open-label, single arm, multiple attack study. Participants acutely treated up to 4 migraine attacks with a portable VNS within 6 weeks. Treatment consisted of two, 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve. Subjects were asked to self-treat once pain became moderate or severe, or after 20 minutes of mild pain. RESULTS: Of 30 enrolled patients, (5M, 25F, average age 39), 26 eligibly treated 79 migraine headaches . At two hours, headache response rate (pain mild or absent at 2 hours) was 46/79 (58%), and 22/79 (28%) were pain free. Average initial pain level was a 1.84 (0-no pain, 1-mild, 2-moderate, 3-severe pain), and dropped 35%, to 1.20 (p<0.0001) by 2 hours . At two hours, 76 of 79 (96%) were improved or had not worsened over baseline. Of 26 patients 20 (77%) responded, i.e., reported mild or nor pain at 2 hours, for at least one treated headache. Among this subset of 20 patients 47/61 (77%) of their treated headaches responded. Treatment related adverse effects were limited to transient muscle or local tissue irritation, and two reports of light headedness, most of which resolved immediately after treatment, and all within two hours of treatment. CONCLUSIONS: These results suggest that nVNS may be an effective and well-tolerated acute treatment for migraine in a responsive subgroup. Randomized controlled trials are warranted. Supported by: ElectroCore, LLC.
Category - Headache: Therapeutics
Wednesday, March 20, 2013 4:39 PM
Moderated Platform Session S40: Headache: Clinical (4:00 PM-5:30 PM)