REN Benefits for Migraine Begin as Early as 2 Weeks

Remote electrical neuromodulation (REN) treatment with the Nerivio device (Theranica Bio-Electronics Ltd, Israel) applied every other day for the prevention of migraine began to show superiority to placebo in warding off migraine attacks as early as 2 weeks, new research shows.

"People who live with migraine want their treatments not only to be effective but to work fast," author Rashmi B. Halker Singh, MD, associate professor of neurology at Mayo Clinic, Scottsdale, Arizona, told Medscape Medical News.

"The [US Food and Drug Administration (FDA)] cleared this device for as needed treatment for migraine in adolescents and adults after studies demonstrated effectiveness after 3 months of treatment, and recently, the FDA cleared it for migraine prevention as well," Halker Singh said. "In this analysis, we wanted to see how quickly the benefit would actually start to take effect."

The findings were presented at the virtual American Headache Society (AHS) Annual Meeting 2023.

REN's FDA approval for acute or preventive treatment for migraine with and without aura was based on data from a randomized controlled trial, led by Stewart J. Tepper, MD, professor of neurology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, and reported at that time by Medscape Medical News.

That study showed that patients who used Nerivio had a mean reduction of 4 migraine days per month from baseline compared with a reduction of only 1.3 days with placebo, for a net therapeutic gain of 2.7 days.

"Neuromodulation is another important treatment option we have to offer people who live with migraine. This is important because some people don't want medication or maybe medication alone is not sufficient. It's just nice to have more options," Halker Singh said.

She and her team sought to assess the temporal patterns of response to REN treatment, used every other day over 2 months for the prevention of migraine.

Patients were randomly assigned to receive either an REN device (n = 95 patients) or a placebo device (n = 84 patients). The group randomized to placebo received stimulation with a sham device.

Patients were instructed to use their device every other day for 8 weeks and to report their migraine attacks daily via an app on their smartphone.

The mean number of monthly migraine days per group was calculated every 2 weeks.

A statistically significant difference between active treatment and placebo became apparent as early as the first tested timepoint of 2 weeks, with REN users reporting a mean reduction of 1.2 days compared with a mean reduction of 0.31 days for the placebo group.

This difference continued to grow in magnitude and remained persistent throughout the 8-week trial.

Individuals with episodic migraine responded sooner with REN versus placebo, generally responding within 2 weeks. Patients with chronic migraine took longer to respond, generally within 6 weeks, Halker Singh said.

Good News for People With Migraine

The results of this study "demonstrate the utility and importance of having treatments specifically targeted at what we know about migraine pathophysiology," Larry Charleston IV, MD, director, Headache and Facial Pain, and professor, neurology and ophthalmology, Michigan State University, East Lansing, commented to Medscape Medical News.

For example, unlike most transcutaneous electrical nerve stimulation devices that modulate A-beta pain fibers, the REN device neuromodulates the A-delta fibers and C-fibers, which are known to be involved in migraine, Charleston said.

"It is certainly good news for people with migraine to have treatment options that target their specific migraine disease and that may provide a preventive benefit as early as 2 weeks," he added.

"Moreover, we have seen that neuromodulation may continue to provide more benefit over time for patients with migraine. This device has already been cleared by the FDA for acute and preventive use in migraine and the 2-week data are encouraging," he concluded. "Many providers such as myself certainly want these newer, migraine-specific treatments that are safe and effective accessible to our patients with migraine disease."

American Headache Society (AHS) Annual Meeting 2023. Abstract #.IO-10 Presented June 17, 2023.

The study was sponsored by Theranica Bio-Electronics Ltd. Halker Singh reports no relevant financial relationships. Charleston reports financial relationships with Allergan, AbbVie, Amgen, Amneal, Biohaven, Haleon, Linpharma, Satsuma, and Teva.

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Credits:

Lead image: Theranica

Image 1: Mayo Clinic, Scottsdale, Arizona

Image 2: Dr Larry Charleston IV

Medscape Medical News © 2023 

Cite this: REN Benefits for Migraine Begin as Early as 2 Weeks - Medscape - Jun 28, 2023.