Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study

NCT07487701 | Active Not Recruiting FDA Device

• 1 other identifier: RWE-012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Preventive pharmacologic therapies for migraine aim to reduce attack frequency and duration and improve quality of life; however, their use, overall benefit and adherence are often limited, especially among patients with chronic migraine. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study evaluated the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in chronic migraine population.

Conditions

Migraine; Chronic Migraine Headache

Keywords

REN; Nerivio; Migraine prevention

Outcome Measures

Primary Outcomes (1)

• Change in average number of monthly migraine days (MMD)

  Change in average number of monthly migraine days (MMD) from baseline to 3-months follow-up questionnaire.

  3 months

Secondary Outcomes (3)

• Patients clinical improvement

  3 months

• Change in migraine attack duration

  3 months

• Device Safety

  3 months

Other Outcomes (2)

• Change in acute migraine drug intake

  3 months

• Reduction of >30% in MMDs

  3 months

Study Arms (1)

Nerivio treatment

ACTIVE COMPARATOR

Nerivio users who were prescribed with the REN wearable for their routine migraine care and treated in a prevention-like manner over 3 consecutive months

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-dministered and vcontrolled 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:

• Patient with migraine
• Prescribed with a Nerivio REN device
• Treat with nerivio in a preventive -like manner over 3 consecutive months from sign up.

Sponsors & Collaborators

• Theranica: lead

Study Sites (1)

Theranica Bio-Electronics Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alit Stark Inbar

  Theranica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: February 20, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)