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OpenTrials
Completed

NCT Number: NCT07336420

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Theranica Bio-Electronics Inc

Bridgewater, New Jersey, 08807, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • VA patients who were prescribed the Nerivio REN device
  • Performed at least 2 REN treatments with both baseline and 2-hours reports

Exclusion criteria

  • None

Treatment and study plan

Nerivio REN device

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.

Primary outcomes

  1. Rescue Medication Usage

    Time frame: 2 hours

    Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment

Secondary outcomes

  1. Pain Relief

    Time frame: 2 hours

    Proportion of treatments in which there was a reduction in headache intensity from moderate or severe headache at baseline to mild or no pain 2 hours post-treatment.

  2. Pain Freedom

    Time frame: 2 hours

    Proportion of treatments in which there was a reduction in headache intensity from mild or moderate or severe headache at baseline to no headache 2 hours post-treatment.

  3. Functional Disability Relief

    Time frame: 2 hours

    Proportion of treatments in which there was at least one-grade improvement in functional disability level at baseline to 2 hours post-treatment.

  4. Functional Disability Freedom

    Time frame: 2 hours

    Proportion of treatments in which there was a reduction in functional disability level at baseline to no functional disability at 2 hours post-treatment.

  5. Freedom from migraine-associated symptoms (Photophobia, Phonophobia, Nausea/Vomiting)

    Time frame: 2 hours

    Proportion of treatments in which there was an absence of at least one of the three associated symptoms 2 hours post-treatment in treatments with reported associated symptoms at baseline.

  6. Treatment intensity

    Time frame: 45 minutes

    Average treatment intensity across all treatments per patient and cohort

  7. Device Safety

    Time frame: up to 5 years

    Rate of serious adverse events, adverse events, and device-related adverse events

Sponsors and collaborators

Lead sponsor

Theranica

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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