The current study assessed the efficacy and safety of remote electrical neuromodulation (REN) in adolescents with migraine.

Current acute treatments for migraine in adolescents may have limited effectiveness, can cause side effects, and may lead to medication overuse. REN is a novel acute treatment of migraine which stimulates upper arm peripheral nerves to induce conditioned pain modulation (CPM) - an endogenous analgesic mechanism. The REN device (Nerivio^®, Theranica Bio-Electronics LTD., Israel) is FDA-cleared for acute treatment of migraine in adults.

This was an open-label, single-arm, multi-center study in adolescents (ages 12-17 years) with migraine. Participants underwent a 4-week run-in phase during which the headaches were recorded in an electronic migraine diary. Eligible participants continued to an 8-week treatment phase in which they were asked to treat their headaches with the device. Pain severity levels, associated symptoms and functional disability were recorded at treatment initiation, 2- and 24-hours post-treatment.

Sixty participants were enrolled of which 39 participants completed a test treatment with REN. Pain relief and pain freedom at 2 hours were achieved by 71% (28/39) and 35% (14/39) participants, respectively. Nausea, photophobia, and phonophobia disappeared at 2 hours in 54% (12/22), 42% (13/31), and 40% (10/25) participants, respectively. 69% (23/33) participants experienced improvement in functional ability at 2 hours. Consistency analyses across multiple attacks showed that 66% and 33% of the participants experienced pain relief and pain-free responses, respectively, in at least half of their treated attacks. Safety analyses were performed on 45 participants who used the device at least once. One device-related adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt.

REN provides clinically meaningful relief of migraine pain and associated symptoms, offering a safe and effective non-pharmacological alternative for acute treatment in adolescents.