Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment
NCT07336420 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 466
Last updated 2026-04-03
Summary
Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options.
This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatment of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment. Findings from this study may help guide clinical decision-making as veterans and providers craft treatment plans that include non-pharmacologic options.
Conditions
- Migraine
- Acute Treatment of Migraine
Interventions
- DEVICE
-
Nerivio REN device
Remote electrical neuromodulation (REN) wearable device for the acute treatment of migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
Sponsors & Collaborators
-
Theranica
lead INDUSTRY
Principal Investigators
-
Alit Stark-Inbar, PhD · Theranica
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-09
- Primary Completion
- 2026-01-25
- Completion
- 2026-01-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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