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One-Year Consistent Safety, Utilization, and Efficacy Assessment of Remote Electrical Neuromodulation (REN) for
Andrea Synowiec1, Alit Stark-Inbar2, Maya Weinstein3
1Allegheny Health Network, Pittsburgh, PA, USA.
Advances in Therapy
|October 19, 2023
Summary
Remote electrical neuromodulation (REN) is a safe and effective non-drug treatment for migraine. Long-term use over 12 months showed consistent pain relief and minimal side effects in patients.
Area of Science:
- Neurology
- Medical Devices
- Pain Management
Background:
- Migraine is a prevalent neurological disorder causing significant disability.
- Effective long-term treatments with minimal side effects are needed.
- Remote electrical neuromodulation (REN) has shown promise for acute migraine treatment.
Purpose of the Study:
- To evaluate the long-term safety, utilization, and efficacy of REN over 12 consecutive months.
- To assess the sustained effectiveness of REN in managing migraine symptoms.
- To determine the tolerability and consistency of REN use in a real-world setting.
Main Methods:
- A study involving 409 participants with migraine using REN for 12 months.
- Data collected electronically from the Nerivio® device.
- Safety assessed via adverse events; utilization by treatment frequency; efficacy by pain intensity and symptom reduction.
Main Results:
- Low incidence of device-related adverse events (1.96%), with no severe events reported.
- Consistent monthly utilization (average 8.05 treatments) and stable efficacy over 12 months.
- 74.1% reported consistent 2-hour pain relief; 26.0% reported consistent pain freedom.
Conclusions:
- REN is a safe and well-tolerated non-drug option for long-term migraine management.
- Sustained efficacy and utilization support REN's role in chronic migraine care.
- The device offers an advantageous treatment with stable outcomes over a year.
