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.

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).