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

NCT ID: NCT07336420

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-09
• Study Completion Date: 2026-01-30

Brief 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 among veterans with migraine, 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 impairmen. 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, headach disorders are particularly common, and their diagnosis has increased throughout the years. Veterans headaches mostly include both migraine and post-traumatic headache (PTH). PTH commonly develops 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 commonly 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, the risk of medication-overuse headache (MOH), or polypharmacy. These challenges are particularly pronounced among veterans where comorbid conditions and polypharmacy often complicate or restrict therapeutic options highlighting the need for effective, well-tolerated, non-pharmacological alternatives. Demonstrating effective pain, functional impairment and symptom relief or freedom 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 have shown the efficacy and safety of the REN wearable device in treating migraine pain and associated symptoms. Given that many PTH cases present with migraine-like characteristics, VA providers may prescribe the REN wearable for PTH with migraine-like symptoms.

This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable among veterans with migraine, with a primary focus on whether they need rescue medications following REN treatment.

Conditions

Migraine; PTH; Acute Treatment of Migraine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nerivio treatment

VA patients who were prescribed with the Nerivio REN device and treated with the device and reported baseline pain were also presented with a 2-hours post-treatment questionnaire at least twice..

Group Type: ACTIVE_COMPARATOR

Nerivio REN device

Intervention Type: DEVICE

Remote electrical neuromodulation (REN) device for the acute treatment of migraines. 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

Interventions

Nerivio REN device

Remote electrical neuromodulation (REN) device for the acute treatment of migraines. 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• VA patiets who were prescribed withthe Nerivio REN device
• Performed REN treatments and reported baseline and 2-hours questionnaires at least twice

Exclusion Criteria

• None

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theranica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alit Stark-Inbar, PhD

Role: PRINCIPAL_INVESTIGATOR

Theranica

Locations

Theranica Bio-Electronics Inc

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

RWE-014

Identifier Type: -

Identifier Source: org_study_id