Remote Electrical Neuromodulation Noninferior to Usual Care for Acute Migraine

Remote electrical neuromodulation may represent a safe and effective option for the acute treatment of migraine.

Remote electrical neuromodulation (REN) may represent a safe and effective option for the acute treatment of migraine, according to a study published in the Journal of Headache Pain.

In REN, the upper arm median and musculocutaneous peripheral nerves are stimulated to induce conditioned pain modulation.

This study was a post-hoc exploratory analysis of data from a randomized double-blind sham-controlled multicenter pivotal study (ClinicalTrials.gov identifier: NCT03361423) in which patients with episodic migraine (ie, 2-8 migraine headaches per month and ≤12 headache days per month; n=99) on a stable migraine preventative treatment regimen were enrolled.

The study included a 1 month-long run-in period during which participants treated their migraines with usual care, followed by a 4 to 6 week-long double-blind treatment phase with active REN or sham device stimulation initiated within 1 hour of migraine onset.  Participants were asked to record pain scores using an electronic diary at baseline and 2 hours after treatment in both study phases, with an additional recording 48 hours after treatment during the double-blind phase. Patients were instructed to continue taking their usual migraine prophylactic during the treatment period and to avoid resorting to rescue medication in the 2 hours following treatment.

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A greater percentage of patients who used REN vs usual care reported pain relief 2 hours after treatment (66.7% vs 52.5%, respectively; P <.05) and  pain relief in ≥1 of 2 attacks at 2 hours following treatment (84.4% vs 68.9%, respectively; P <.05).

A higher percentage of patients using REN vs usual care also had pain freedom at 2 hours in ≥1 of the 2 attacks (50.0% vs 36.7%, respectively; P =.050). REN and usual care had comparable efficacy for achieving freedom from pain at 2 hours post-treatment.

Study limitations include its post-hoc nature and small sample size.

“[O]ur findings suggest that REN may be useful as an alternative or adjunctive acute migraine treatment,” concluded the study authors.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Rapoport AM, Bonner JH, Lin T, et al. Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications. J Headache Pain. 2019;20(1):83.