Noninvasive Vagus Nerve Stimulation Cleared for Paroxysmal Hemicrania and Hemicrania Continua

The Food and Drug Administration (FDA) granted 510(k) clearance for the treatment of  paroxysmal hemicrania (PH) and hemicrania continua (HC) with noninvasive vagus nerve stimulation (nVNS) (gammaCore; ElectroCore, Rockaway, NJ). 

This expands the indications for nVNS, which was previously clearedfor acute and preventative treatment of cluster headache, for which it is considered a first-line treatment option.

Clearance was based on data collected from multiple clinical audits, case series, and case reports that included data from 14 individuals with PH and 19 with HC. After using nVNS, 79% of these individuals experienced clinically meaningful benefits, including decreases in the severity of persistent pain and reductions in the frequency, severity, and duration of exacerbations or attacks. There were no serious or unexpected adverse events.

“gammaCore is the first treatment, drug or device, to be indicated for the treatment of paroxysmal hemicrania or hemicrania continua,” said Eric Liebler, senior vice president of Neurology at electroCore, Inc. “The rare ability of nVNS to address several of the mechanistic pathways that contribute to the pain and symptoms of headache allows gammaCore to be used by patients as a treatment option for most forms of primary headache. We would like to thank the Division of Neuromodulation and Physical Medicine Devices and their colleagues at the FDA for their efforts to review and clear these new indications for gammaCore."

nVNS is the first noninvasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache via mild transcutaneous electric stimulation to the vagus nerve. When placed over the vagus nerve, nVNS stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. The nVNS should not be used for individuals who have an active implantable medical device, a metallic device implanted at or near the neck, or are using another device at the same time or any portable electronic device.

Safety and efficacy of nVNS have not been evaluated for individuals diagnosed with narrowing of the arteries, those who have had vagal nerve surgery at the neck, children under age 12 years, people who are pregnant, or individuals with clinically significant hypertension, hypotension, bradycardia, or tachycardia.