Novel nerve stimulation device provides migraine pain relief

Cefaly Technology’s nerve stimulation device, when compared with sham stimulation, was more effective in delivering pain relief and freedom from most bothersome migraine symptom, phase 3 trial data show.

Cefaly Dual transmits small electrical impulses through a self-adhesive electrode that is placed on the patient’s forehead, providing relief in about 1 hour, according to the manufacturer.

The device “directly stimulates the supraorbital nerves in the forehead, a branch of the trigeminal nerve, a key player in migraine pathophysiology,” Deena E. Kuruvilla, MD, medical director of the Westport Headache Institute in Southport, Connecticut, and medical adviser to Cefaly Technology, said during a pre-recorded presentation for the virtual American Headache Society Meeting.

Kuruvilla and colleagues evaluated the efficacy of the device in 538 adults with episodic migraine with or without aura, at least one migraine-related symptom (eg, photophobia, phonophobia or nausea and/or vomiting) and 2 to 8 moderate-to-severe migraine days monthly. These patients were assigned in an approximate 1:1 ratio to receive active stimulation with Cefaly Dual or sham stimulation. They were instructed to avoid rescue medications before or while using the device.

“Participants were trained to keep a headache diary and use the study device at their home,” Kuruvilla said. “They were asked to apply the neurostimulation device for a 2-hour continuous session within 4 hours of a qualifying migraine attack for a 2-month period.”

The researchers wrote that when it came to the trial’s two primary endpoints, Cefaly Dual was more effective than the sham stimulation in achieving pain relief at 2 hours (25.5% vs. 18.3%; P = 0.43) and freedom from the most bothersome migraine symptom (56.4% vs. 42.3%; P = .001).

Most secondary endpoints also favored Cefaly Dual use: proportions of participants who experienced pain relief at 2 hours (69.5% vs. 55.2%; P = .001); proportion of participants who reported no migraine-associated symptoms at 2 hours (42.5% vs. 34.1%; P = .044); proportion of participants who experienced sustained pain freedom at 24 hours (22.8% vs. 15.8; P = 0.39); and proportion of participants who experienced sustained pain relief at 24 hours (45.9% vs. 34.6%; P = .006). Only one secondary endpoint favored the sham stimulation: participants who needed rescue medications between 2 and 24 hours of using either device (37.6% vs. 31.7%); however, the difference was not statistically significant. The most common adverse events reported during the trial were paresthesia, discomfort or burning on the forehead.

The researchers wrote that because some acute migraine treatments lead to contraindications and are associated with poor tolerability and a risk for medication-overuse headache, Cefaly Dual “offers a safe alternative to pharmacological treatments.”

The FDA cleared Cefaly Dual for over-the-counter sales as an acute and preventive migraine treatment last fall, making it the first dual-purpose external trigeminal nerve stimulator device for migraine headaches to become available OTC in the United States, according to a press release.

References:

Cefaly. How it works. Available at: https://www.cefaly.com/how-it-works. Accessed June 8, 2021.

PRNewswire.com. Now Over-the-Counter: FDA Clears CEFALY DUAL Migraine Treatment for Use Without a Prescription. Available at: https://www.prnewswire.com/news-releases/now-over-the-counter-fda-clears-cefaly-dual-migraine-treatment-for-use-without-a-prescription-301150599.html. Accessed June 8, 2021.