FDA Clears Wearable Brain Neuromodulation Device for Acute Migraine

The Food and Drug Administration (FDA) has cleared Relivion^® (Neurolief), a noninvasive, multichannel, wearable brain neuromodulation system for at home treatment of acute migraine. 

Relivion is worn as a headset delivering stimulation to 6 branches of the occipital and trigeminal nerves through 3 adaptive output channels. This allows for the release of neurotransmitters in the brainstem and modulation of brain networks associated with control of pain and mood. The device is a self-learning system that collects information to adapt and improve the treatment over time. A companion mobile app called e-Relief™ displays treatment status and transmits information to the e-Relief™ cloud database.

The FDA clearance was based on efficacy and safety data from the RIME study (ClinicalTrials.gov: NCT03631550), a prospective, randomized, double-blind, placebo-controlled trial that evaluated Relivion in 131 patients with migraine with or without aura. Results showed that 46% of patients in the Relivion arm reached complete pain freedom compared with 11.8% in the control arm. Moreover, 75% of patients treated with Relivion achieved complete freedom of their most bothersome symptom (MBS; ie, phonophobia, photophobia, or nausea) within 2 hours after treatment vs 46.7% in the control group.

Findings also showed a significantly greater proportion of patients in the Relivion arm achieved complete freedom of migraine symptoms (defined as freedom from pain and MBS) at 2 hours after treatment (47.2% vs 11.1% in the control arm). Relivion treatment was also associated with significantly greater pain relief 2 hours post treatment compared with control (60% vs 37%).

“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,” said Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth, who was the principal investigator on the pivotal international trial

The device is expected to be available in the US in late summer 2021.

For more information visit neurolief.com.

Reference

1.    Relivion^® wearable brain neuromodulation technology cleared by FDA for the treatment of migraine. [press release]. Tampa, FL and Netanya, Israel: Neurolief; March 2, 2021. 

2.    Neurorelief. Neurorelief: Technology. https://www.neurolief.com/technology/. Accessed March 2, 2021.