This real-world observational study evaluates the safety and tolerability of remote electrical neuromodulation (REN; Nerivio^®) in patients who have utilized it more frequently than the current label indication for migraine treatment. REN is an FDA-cleared, drug-free, prescribed wearable device approved for the acute treatment of migraine and/or every-other-day prophylactic treatment in patients aged 8 years and older.

Using data from 1,863 patients with migraine, the study examined REN use patterns that exceeded labeling, including multiple treatments within a single day and daily use. Across more than 80,000 treatment sessions, device?related adverse events were rare (<1% of patients), negligible to moderate in severity and resolved without medical intervention. Importantly, no serious device?related adverse events were reported, and most patients continued therapy after reporting an event.

Reena Rastogi, MD

Reena Rastogi, MD,  et al., pediatric neurologist and Pediatric Headache Program director at Phoenix Children’s, is a co-author of this research. Read the Study

Phoenix Children's Pediatric Headache Clinic accepts referrals for children and adolescents with migraine, chronic headache, post-traumatic headache and complex or refractory headache disorders. To refer a patient or request a consultation, call 602-933-KIDS (5437) or submit a referral online.

REFERENCE

Werner K, et al. A Real-World Evidence Study on US Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment. Pain Ther. 2026;15(3):711–720. doi:10.1007/s40122-026-00828-9.