Nerivio® (by Theranica Bio-Electronics Ltd, Tel Aviv, Israel) is a wireless, wearable, noninvasive, battery-operated, remote electrical neuromodulation device controlled by a smartphone application. It is US FDA authorized for the acute treatment of migraine with or without aura in people 12 years and older in the US, and European Conformity (CE) marked for the same indication in the EU. The American Headache Society Consensus Statement recommends Nerivio as a tier 2 treatment for migraines. This review summarizes a series of five independent clinical trials and two real-world evidence studies that established safety, tolerability and efficacy of Nerivio in treating migraine attacks. It further provides up-to-date practical information on device usability. Based on findings of this review, Nerivio offers a safe and effective nonpharmacological alternative for acute treatment in patients with chronic (and nonchronic) migraine.
Keywords: CPM; MOH; REN; acute migraine treatment; adolescents; headache; migraine; migraine chronification; randomized controlled trial; real-world evidence.
Nerivio® is a Bluetooth-enabled device controlled via smartphones for the treatment of migraine attacks. The device is placed on the arm and kept in place with an armband, delivering nonpainful electrical stimulation which in turn activates signals in the brain to release substances that help break pain. The device is cleared by the US FDA in the USA for the acute treatment of migraine in people 12 years or older with episodic or chronic migraine. This review provides a summary of several clinical trials and real-world evidence studies that helped show the safety, tolerability and efficacy of Nerivio as a migraine treatment. Based on these findings, Nerivio can offer a safe, well tolerated nonmedication option for patients with migraine.