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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Acute Treatment of Migraine
• Intervention / Treatment: Device: Nerivio REN device

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.

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Theranica Bio-Electronics Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nerivio treatment; VA patients who were prescribed the REN wearable device and had at least 2 treatments with reports on baseline and 2-hours post-treatment questionnaires.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Medication Usage	Proportion of treatments in which patients did not use additional prescribed medications within 2-hours following REN treatment	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	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 hours
Pain Freedom	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.	2 hours
Functional Disability Relief	Proportion of treatments in which there was at least one-grade improvement in functional disability level at baseline to 2 hours post-treatment.	2 hours
Treatment intensity	Average treatment intensity across all treatments per patient and cohort	45 minutes
Functional Disability Freedom	Proportion of treatments in which there was a reduction in functional disability level at baseline to no functional disability at 2 hours post-treatment.	2 hours
Freedom from migraine-associated symptoms (Photophobia, Phonophobia, Nausea/Vomiting)	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.	2 hours
Device Safety	Rate of serious adverse events, adverse events, and device-related adverse events	up to 5 years

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Principal Investigator: Alit Stark-Inbar, PhD, Theranica

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Actual): January 25, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Remote Electrical Neuromodulation; Nerivio; Acute Treatment of Migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: RWE-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No