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

Conditions

• Chronic Migraine Headache
• Migraine

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Feb 20, 2026

Status verified

Mar 2026

Primary completion

Apr 15, 2026

Completion

Apr 15, 2026

Study Design

Enrollment

150 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Active Comparator: Nerivio treatment
  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

Primary Outcome Measure

Change in average number of monthly migraine days (MMD) [ Time Frame: 3 months ]

Locations (1)

Find similar trials in Bridgewater, NJ

Related Studies

• Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Children and Adolescents (Ages 6-17)
  PHASE3 · Recruiting · AbbVie · Huntsville, Alabama
• Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
  PHASE3 · Enrolling By Invitation · AbbVie · Huntsville, Alabama
• Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
  PHASE3 · Recruiting · AbbVie · Birmingham, Alabama
• A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
  PHASE3 · Recruiting · Pfizer · Phoenix, Arizona