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

NCT07336420 | Enrolling By Invitation Phase 4 FDA Device

• 1 other identifier: RWE-014
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Migraine; PTH; Acute Treatment of Migraine

Keywords

Nerivio; Remote Electrical Beuromodulation; Medication Overuse

Outcome Measures

Primary Outcomes (1)

• Rescue Medication Usage

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

  2 hours

Secondary Outcomes (7)

• Pain Relief

  2 hours

• Pain Freedom

  2 hours

• Functional Disability Relief

  2 hours

• Functional Disability Freedom

  2 hours

• Freedom from each migraine-associated symptom (Photophobia, Phonophobia, Nausea/Vomiting)

  2 hours

Study Arms (1)

Nerivio treatment

ACTIVE COMPARATOR

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..

Device: Nerivio REN device

Interventions

Nerivio REN device 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

Nerivio treatment

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica Bio-Electronics Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Prescription Drug Overuse

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Alit Stark-Inbar, PhD

  Theranica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open label, single arm, Real-World-Evidence (RWE) study

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 13, 2026
• Study Start: January 9, 2026
• Primary Completion: January 25, 2026
• Study Completion: January 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)