U.S. Veterans Using Remote Electrical Neuromodulation for Migraine: A Prospective Real-World Evidence Study of
Krista N Brooks-Horrar1, Elena Crisan2, Eden Mama3
1VHA Headache Center of Excellence, Tennessee Valley Health Care System, Nashville, TN 37212, United States.
Introduction:
Among U.S. veterans, migraine and other headache disorders are common, and frequently co-occur with other comorbidities, highlighting the need for effective, well-tolerated, drug-free treatment options. Remote electrical neuromodulation (REN) is a non-pharmacological wearable device for the acute and/or preventive treatment of migraine. This study evaluated treatment patterns, acute medication use, effectiveness, and safety of REN wearable among veterans.
Materials And Methods:
Prospective real-world evidence (RWE) cohort study included veterans prescribed REN as part of routine clinical care. Data were collected through the REN mobile application (Nerivio). Outcomes included the proportion of treatments requiring rescue medications following REN use, and treatment effectiveness as assessed by patients reporting pain, functional disability, and associated symptoms at baseline and 2-hour post-treatment. Safety was assessed through adverse-event reports.
Results:
Veterans (n = 466; mean age 49.1 ± 11.8; 51.3% male, 47.9% female) conducted 28,274 REN treatments. Among treatments with rescue medication data, prescribed medications were not used in 76.7% of the REN treatments (60.9% REN standalone, 15.8% REN + over-the-counter medications). Pain relief and freedom were achieved by 66.7% and 26.6% of patients, respectively; functional disability relief and freedom reported by 69.3% and 33.3%, and freedom from associated symptoms by 56.5% of patients. Post hoc sub-analyses showed greater effectiveness with early treatment initiation, and among females compared with males. Only 2 patients reported (0.4%) device-related adverse events, both were not serious.
Conclusions:
This RWE study demonstrated effectiveness and safety of REN for the acute treatment of migraine among veterans, who reported not using prescribed rescue medications in most of their REN treatments. Given the high burden of comorbidities and polypharmacy among veterans, REN represents a clinically relevant drug-free therapeutic option, supporting its broader integration into veteran migraine care.
Clinical Trial Registration:
ClinicalTrial.Gov; Identifier: NCT07336420.
