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A Real-World Evidence Study on US Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment

Year: 2026

Type: article

Abstract: Remote electrical neuromodulation (REN) is an FDA-cleared, nonsignificant-risk, drug-free, prescribed wearable device (Nerivio®) for the acute treatment of migraine and/or every other day for prophylactic treatment in patients aged 8 years and older. Despite established efficacy within labeled use parameters, some patients adopt more frequent treatment regimens, including multiple treatments within a single day, daily use, or both. This study assessed the safety and tolerability of REN when used at frequencies exceeding the labeled indication. Real-world observational data from patients with migraine using REN with frequent treatment patterns were collected. Safety assessments evaluated all adverse events (AE) reports, with emphasis on device-related AEs (dAEs), categorized by severity and seriousness per regulatory standards. A total of 1863 patients with migraine (82.1% female, mean age of 38.8 ± 20.1 years) were eligible: (1) 1654 treated multiple times a day, at least once, (2) 310 treated daily; 101 patients met both patterns. Safety profile was favorable, with a total of 17 patients reporting dAEs (0.91% of patients, 0.02% of treatments). Of them, 16 dAEs reported in multiple treatments per day group (0.97% of patients, 0.05% of treatments), and 6 dAEs in daily treatment group (1.94% of patients, 0.01% of treatments) with 5 dAEs overlapping between the groups (reported by patients who met both criteria). dAEs were infrequent, negligible to moderate in severity, and resolved without medical intervention. No serious dAEs were observed, and the majority of patients continued to use REN after reporting the dAE. REN is a safe and well-tolerated treatment for migraine, even when used more frequently than the labeled indication. These findings support its use in real-world clinical practice, including for patients with severe or highly frequent attacks who may need additional treatments. ClinicalTrial.gov NCT07336056. Migraine is a disabling disorder that can disrupt daily life. Remote electrical neuromodulation is a wearable device that treats migraine without medication, by sending gentle electrical signals to nerves in the arm, which activate the body’s natural pain-control system. The US FDA cleared it for people aged 8 years and older as a nonsignificant-risk device, meaning it poses minimal risk to users. Patients can use the remote electrical neuromodulation either when a migraine starts or every other day to help prevent attacks. Some people use it more often, such as several times a day or every day. This was an observational study that examined whether frequent treatment beyond the indication with remote electrical neuromodulation in real-life setting is safe. Data from 1863 people who used remote electrical neuromodulation often was reviewed, looking at voluntarily reports of adverse events and their severity. Two patterns were studied: several treatments per day (four or more treatments in 1 day), and every day (6–7 treatments per week over a month). The results show that remote electrical neuromodulation is safe, even with frequent use. Fewer than 1% of patients reported mild to moderate treatment-related side effects. No serious side effects occurred, and most patients continued treatment after reporting an adverse event, supporting the remote electrical neuromodulation as a safe option for people with severe or frequent migraine attacks who may require additional treatments.

Source: Pain and Therapy

DOI: 10.1007/s40122-026-00828-9