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Introduction <p>Remote electrical neuromodulation (REN) is an FDA-cleared, nonsignificant-risk, drug-free, prescribed wearable device (Nerivio<sup>®</sup>) for the acute treatment of migraine and/or every other day for prophylactic treatment in patients aged 8&#xa0;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.</p> Methods <p>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.</p> Results <p>A total of 1863 patients with migraine (82.1% female, mean age of 38.8 ± 20.1&#xa0;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.</p> Conclusion <p>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.</p> Trial Registration <p>ClinicalTrial.gov NCT07336056.</p>

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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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年3月26日

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  • Reena G. Rastogi,
  • Jason A. Santiago,
  • Alicia Chang,
  • Eden Mama,
  • Alit Stark-Inbar,
  • Alon Ironi,
  • Alan R. Towne,
  • Klaus Werner

摘要

Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Trial Registration

ClinicalTrial.gov NCT07336056.