Relivion Headset for Migraines Cleared in Europe

Neurolief, an Israeli company, has won European regulatory clearance (CE Mark) for its Relivion system to treat migraines.

Intended as an over-the-counter product, the non-invasive Relivion device delivers pulses of electric current into the patient’s brain. The headset is designed to stimulate the occipital and trigeminal nerves and the amount and type of modulation can be controlled via an app on a paired smartphone.

“I believe that the Relivion device from Neurolief has great potential to improve acute migraine therapy,” said Alan Rapoport, M.D., clinical professor of neurology at The David Geffen School of Medicine at UCLA, past president of the International Headache Society (IHS), and the founder and director-emeritus of The New England Center for Headache. “Not only is it designed to stimulate both the trigeminal and occipital nerves simultaneously to help alleviate migraine without having to worry about side effects from medications, but it does so via a comfortable headset that is different from anything available today. These attributes combine to offer a therapy that migraine sufferers can feel good about using – and in turn receive consistent treatment to help them live a more disability-free, productive, fulfilling life.”

Some info on the study that led to the clearance, according to Neurolief:

The CE mark was granted based on data from a randomized, double-blind, placebo-controlled clinical trial which showed very high efficacy and safety for Relivion in the treatment of migraine headache. Seventy-six percent of the participants achieved headache relief after only one treatment while no serious adverse effects were observed. Full results of the trial will be presented at the American Headache Society’s 61st Annual Scientific Meeting on Saturday, July 13, 2019 in Philadelphia.