Evaluating the effectiveness and safety of a remote electrical neuromodulation wearable device in treating chronic and episodic migraine: a retrospective, observational real-world evidence from India
Year: 2025
Type: article
Study design: Observational Study
Abstract: Background The remote electrical neuromodulation (REN) wearable device offers a noninvasive, non-pharmacological option for migraine management, but its role in Indian healthcare remains unexplored.Research design and methods This retrospective, observational, real-world analysis included patients prescribed REN (Nerivio®) by neurologists across India. Deidentified data were collected via the Portea Medical patient support program, with a three-month follow-up. The primary outcome assessed the effectiveness and safety of the device. Secondary outcomes included changes in headache frequency and medication regimes.Results The study population included 1033 patients (mean [SD] age: 38.8 [13] years; 74.8% female; 84.6% with chronic migraine). At two hours post-treatment with REN, 57.3% reported pain relief, 29.4% achieved pain freedom, 47.1% experienced relief from functional disability, and 26.1% reported complete freedom from functional disability. At three months, 70.3% found REN effective. The mean visual analog scale score for pain severity decreased by 2.3 units (p < 0.001). No adverse events occurred in 38.7% of patients. REN usage significantly reduced monthly headache days, frequency of oral medication use, and medicine dosage.Conclusion REN is an effective, safe, and well-tolerated non-pharmacological option for migraine management in India. However, long-term studies are necessary to extend these findings across diverse populations.Trial Registration ClinicalTrials.gov (CTRI/2024/11/076750).
Source: Expert Review of Medical Devices
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4414613490