FDA Clears Vagus Nerve Stimulator for Migraine Pain

Andy · Jan 30, 2018

The US Food and Drug Administration (FDA) has cleared the hand-held, noninvasive vagus nerve stimulator (nVS) gammaCore (electroCore LLC) for the treatment of migraine pain in adults, the manufacturer announced earlier today.

The new 510(k) clearance will expand the device's label from just treating episodic cluster headache pain, an indication that the FDA approved in April 2017.

Courtesy of gammaCore

After the portable device is placed over the vagus nerve in the neck, it releases a mild electrical stimulation to the nerve's afferent fibers.

"With the FDA's decision to release gammaCore for migraine, patients now have access to an effective and safe therapy which can be self-administered to acutely treat the pain associated with migraine," Stephen D. Silberstein, MD, professor of neurology and director of the Headache Center at Thomas Jefferson University, Philadelphia, Pennsylvania, said in a news release.
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https://www.medscape.com/viewarticle/891930?src=soc_fb_180203_mscpedt_news_mdscp,mdscp_migrane&faf=1

Trish · Jan 30, 2018

PRESTO included 243 patients with episodic migraine. Significantly more members of the group receiving nVNS were pain free at 30 minutes (12.7%) than those receiving a sham treatment (4.2%; P = .01). There was also a greater percentage of the nVNS group who were pain free at 60 minutes (21% vs 10%, respectively; P = .02).
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Although between-group differences for being pain free at 120 minutes missed statistical significance (30.4% vs 19.7%, respectively; P = .07), significance for this outcome was found after a post hoc repeated-measures test (odds ratio, 2.3; P = .01).

The secondary endpoint of mild or no pain at 2 hours was also significantly greater in those receiving neuromodulation (40.8% vs 27.6%; P= .03), as was pain reduction at 2 hours (34.8% vs 5.4%; P = .004).

"The PRESTO data suggests that gammaCore was rapidly effective, well-tolerated, and practical for the acute treatment of episodic migraine," principal investigator, Cristina Tassorelli, MD, director of the Headache Science Center at the C. Mondino National Neurological Institute, Pavia, Italy, in a press announcement released in 2017.
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So it looks like it helps a statistically significant minority of people, but not a dramatic cure, and the majority are not helped.

guest001 · Jan 31, 2018

I am curious about this vagus nerve malarkey... I suppose this clearance of this device could herald research for other diseases.

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FDA Clears Vagus Nerve Stimulator for Migraine Pain

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