Remote Electrical Neuromodulation Device Helps Prevent Migraines
A remote electrical neuromodulation (REN) device, when used every other day, is effective and safe for acute and preventive migraine therapy either on its own or as an adjunct therapy, according to a study published in the journal Headache.
There were 248 participants in this prospective, randomized, double-blind, placebo-controlled, multicenter study (NCT04828707). Participants had a history of reported episodic or chronic migraine and either were not taking any medication for headache treatment or were taking a single migraine prevention medication. Participants were followed for 4 weeks to establish baseline characteristics along with 8 weeks of treatment. Individuals enrolled in the study reported symptoms daily via an electronic diary. The 95 participants in the intention-to-treat (ITT) cohort used a REN device (Nerivio; Theranica USA, Bridgewater, NJ), every other day for 45 minutes, while the control participants used a placebo apparatus that created electrical pulses at a lower frequency. The Nerivio device has received 510(k) clearance by the Food and Drug Association for the acute treatment of episodic or chronic migraine in people 12 years and older. This REN device consists of a wireless, noninvasive remote electrical-stimulation wearable worn on the upper arm at the onset of a migraine that is controlled by an application accessed on a separate device (such as a telephone or tablet) by the user.
The primary outcome was measurement of the mean change in migraine days reported in a month. Participants with episodic and chronic migraines were evaluated as subgroups. Results indicated that those in the ITT cohort reported a decrease of nearly 3 days in the number of reported migraine days per month. This group also experienced a reduced number of days they needed to use their acute medication when compared with the control cohort (3.5 vs 1.4 days; P=.001). More participants in the ITT cohort saw their moderate and/or severe headaches reduced by at least 50% (51.6% vs 35.7%; P = .033).
According to researchers: “REN is a safe and effective preventive treatment for migraine, offering a much-needed non-pharmacological alternative either as a stand-alone preventive therapy or in combination with pharmacological therapies to further enhance preventive impact.”