NCT07336420

Treatment Patterns Among US Veterans Using Remote Electrical Neuromodulation (REN) for Migraine Treatment

Treatment Patterns, Medication Usage, Effectiveness, and Safety Among US Veterans Using the Remote Electrical Neuromodulation (REN) Wearable Device for Migraine Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Migraine is a highly prevalent and disabling neurological disorder characterized by recurrent headache attacks often accompanied by nausea, sensitivity to light or sound, and functional impairment. Affecting approximately 14% of the global population, migraine substantially reduces quality of life and interferes with daily functioning. Within the veteran affairs (VA) population in the United States, headache disorders including migraine, are particularly common, and their diagnosis has increased throughout the years. In this population, headache disorders commonly develop following service-related injuries or exposures, such as service eras and traumatic brain injury (TBI), contributing their prevalence and severity. Moreover, veterans with headache disorders frequently present with multiple comorbidities, including post-traumatic stress disorder (PTSD), depression, anxiety, sleep disorders, chronic musculoskeletal pain, neck and back disorders, and TBI-related symptoms. This complex clinical profile increases disability, complicates treatment decisions, and can limit the use of certain pharmacologic therapies due to contraindications or polypharmacy. Despite the availability of multiple therapeutic options, many patients face challenges in managing their migraine due to limited drug tolerability, contraindications, or medication-overuse headache (MOH). These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict pharmacological therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment, and symptom freedom or relief, with minimal reliance on additional medications, is particularly relevant in this population. This need is supported by the adoption of non-pharmacological treatment options by the Veterans Health Administration (VHA). Remote electrical neuromodulation (REN) is a prescribed wearable device for non-invasive, non-pharmacological treatment of migraine, indicated for acute and/or preventive treatment in patients aged 8 years and older. Many studies, including randomized controlled trials and real-world evidence studies, have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms. This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable for the acute treatments of migraine among veterans, with a primary focus on whether they need rescue medications following REN treatment, as well as on treatment effectiveness.

Conditions

• Migraine
• Acute Treatment of Migraine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-09
• Primary completion: 2026-01-25
• Completion: 2026-01-30
• First posted: 2026-01-13
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study