ArticlePain and therapy2026
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.
Article in Pain and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07336056 (Safety Profile of High-Frequency Use of a Remote Electrical Neuromodulation), which is not on this map. Not yet cited in PubMed.
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Safety Profile of High-Frequency Use of a Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment
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8 authors.
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Abstract
introductionRemote electrical neuromodulation (REN) is an FDA-cleared, nonsignificant-risk, drug-free, prescribed wearable device (Nerivio
methodsReal-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.
resultsA 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.
conclusionREN 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.
trial registrationClinicalTrial.gov NCT07336056.
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