The US Food and Drug Administration (FDA) has cleared the first noninvasive multichannel brain neuromodulation system to treat acute migraine pain.
The Relivion system, from Neurolief, is an adjustable headset that delivers modulated pulses of electric current through adaptive output channels around the head to six branches of the occipital and trigeminal nerves.
It is Cloud-enabled and linked to a mobile phone app. The device is designed to learn over time and to provide personalized therapy for individual patients, the company says. It does not require a prescription.
The FDA approved the Relivion system on the basis of a multicenter, prospective, randomized, double-blind, placebo-controlled trial involving 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura.
The study showed that 46% of patients who used the Relivion device achieved complete relief of migraine pain, compared with 11.8% of patients in a control group that used a placebo device.
In addition, 75% of patients in the active stimulation group achieved complete freedom of “most bothersome symptom” within 2 hours following treatment, compared to 46.7% of patients in the control group.
Pain relief was also significantly higher in the active-treatment group than in the control group 2 hours after treatment (60% vs 37%). No serious adverse events were reported.
“The FDA clearance of the Relivion non-invasive device is an important event for those suffering from migraines, as it is the only neuromodulation technology thus far that has demonstrated statistically significant efficacy in providing complete freedom of migraine symptoms within 2 hours after treatment, in a sham-controlled clinical trial,” principal investigator Stewart J. Tepper, MD, professor of neurology, Geisel School of Medicine, Dartmouth College, Hanover, New Hampshire, said in a company news release.
“Patients will now have access to a highly effective, easy-to-use, non-invasive, and drug free therapeutic option that will help them regain control of their lives,” said Tepper.
Migraine affects 39 million men, women, and children in the United States and leads to 1.2 million emergency department visits each year, according the Migraine Research Foundation.
The FDA granted the Relivion system breakthrough device designation. The device was approved for migraine in Europe in 2019.
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