Clinical Scorecard: A Real-World Evidence Study on U.S. Patients Demonstrating Safety of High-Frequency Use of the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment

At a Glance

Key Highlights

• The observational study evaluated REN use exceeding current labeling, including multiple treatments in one day and daily use.
• The analysis included more than 80,000 treatment sessions among 1,863 patients.
• Device-related adverse events were reported in fewer than 1% of patients.
• Reported events were negligible to moderate in severity and resolved without medical intervention.
• No serious device-related adverse events were reported; most patients continued therapy after reporting an event.

Guideline-Based Recommendations

Diagnosis

Management

• REN is an FDA-cleared, prescribed, drug-free wearable device for acute migraine treatment and/or every-other-day prophylactic treatment in patients aged 8 years and older.

Monitoring & Follow-up

• The study assessed adverse events during use patterns that exceeded labeling, including multiple treatments within a day and daily use.

Risks

• Device-related adverse events occurred in fewer than 1% of patients and were negligible to moderate in severity.
• Reported events resolved without medical intervention; no serious device-related adverse events were reported.

Patient & Prescribing Data

Real-world data from 1,863 U.S. patients with migraine; REN is indicated for patients aged 8 years and older.

The study examined more frequent use than current labeling, including multiple treatments in one day and daily use, across more than 80,000 sessions. Most patients continued therapy after reporting an adverse event.

Clinical Best Practices

• Use REN as a prescribed device for acute migraine treatment and/or every-other-day prophylactic treatment in patients aged 8 years and older, as described in the source.
• The study reports safety outcomes for use exceeding labeling; it does not provide a recommendation to exceed labeling.

Related Resources & Content

• Werner K, et al. 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. Pain Ther. 2026;15(3):711–720. doi:10.1007/s40122-026-00828-9.