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Remote electrical neuromodulation for migraine prevention: A double-blind, randomized, placebo-controlled clinical trial. Headache Tepper, S. J., Rabany, L., Cowan, R. P., Smith, T. R., Grosberg, B. M., Torphy, B. D., Harris, D., Vizel, M., Ironi, A., Stark-Inbar, A., Blumenfeld, A. M. 2023

Abstract

OBJECTIVE: To assess the clinical efficacy of remote electrical neuromodulation (REN), used every other day, for the prevention of migraine.BACKGROUND: Preventive treatment is key to managing migraine, but it is often underutilized. REN, a non-pharmacological acute treatment for migraine, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine.METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled, multi-center trial, with 1:1 ratio. The study consisted of a 4-week baseline observation phase, and an 8-week double-blind intervention phase in which participants used either REN or a placebo stimulation every other day. Throughout the study, participants reported their symptoms daily, via an electronic diary.RESULTS: Two hundred forty-eight participants were randomized (128 active, 120 placebo), of which 179 qualified for the modified intention-to-treat (mITT) analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint, change in mean number of migraine days per month from baseline, with mean reduction of 4.0± SD of4.0days (1.3±4.0 in placebo, therapeutic gain=2.7 [confidence interval -3.9 to -1.5], p<0.001). The significance was maintained when analyzing the episodic (-3.2±3.4 vs. -1.0±3.6, p=0.003) and chronic (-4.7±4.4 vs. -1.6±4.4, p=0.001) migraine subgroups separately. REN was also superior to placebo in reduction of moderate/severe headache days (3.8±3.9 vs. 2.2±3.6, p=0.005), reduction of headache days of all severities (4.5±4.1 vs. 1.8±4.6, p<0.001), percentage of patients achieving 50% reduction in moderate/severe headache days (51.6% [49/95] vs. 35.7% [30/84], p=0.033), and reduction in days of acute medication intake (3.5±4.1 vs. 1.4±4.3, p=0.001). Similar results were obtained in the ITT analysis. No serious device-related adverse events were reported in any group.CONCLUSION: Applied every other day, REN is effective and safe for the prevention of migraine.

View details for DOI 10.1111/head.14469

View details for PubMedID 36704988