Wearable remote electrical neuromodulation device improves outcomes in migraine

Key takeaways:

• Researchers examined the effects of a remote neuromodulation device in patients with migraine.
• At 2 hours, pain and functional disability relief were significant.

SAN DIEGO — A wearable remote electrical neuromodulation device provided consistent efficacy and clinically meaningful benefit to those with migraine, according to a poster presentation at the American Headache Society Annual Scientific Meeting.

“We see that patients do typically take drug therapy for migraine, but we did want to see if we could get coverage for a device, as no devices had been,” Sandy Garas, PharmD, head of U.S. medical affairs at Theranica USA, told Healio. “It was important to kick off this pilot and demonstrating the efficacy.”

Researchers at Theranica and Highmark Inc. sought to determine efficacy of Nerivio, manufactured by Theranica, a remote electrical neuromodulation (REN) wearable device to treat migraine and to assess its necessity as standard-of-care for acute treatment and receive appropriate insurance coverage.

They conducted a feasibility study of the REN device, which included 381 participants (mean age 40.5±13.2 years; 91% female) who had failed at least one previous standard-of-care therapy, were at risk of medication overuse or adverse drug interaction with concurrent medication; or were pregnant, had the potential for pregnancy or breastfeeding post-pregnancy.

Participants wore the device with data accumulated over 3 to 6 months, with the primary outcome change in the Migraine Disability Assessment Test (MIDAS) score from baseline to 3 to 6 months with the device. Secondary outcomes included device efficacy 2 hours post treatment, patient satisfaction and REN refill rate.

MIDAS score in participants who wore the device decreased from 58.3 at baseline to 46.2 after 3 to 6 months.

At 2 hours post treatment, 77.8% of respondents reported pain relief, 70.6% reported functional disability relief and 50% logged functional disability freedom, with 33% reporting pain freedom.

Data additionally showed 38.8% of participants refilled their REN device at least once after initial treatment, with the average number of REN devices per patient per year was 3.7.

Patient-reported happiness was 80% overall satisfaction, 86% for effectiveness and 90% for tolerability.

“We demonstrated that (the device had) statistically significant and clinically meaningful benefits to migraine patients,” Garas said. “It ultimately led to our first payer coverage with Highmark.”