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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Theranica
Study ID
NCT07487701
Status
Completed

Conditions

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 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

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. Remote electrical neuromodulation (REN) is a non-invasive FDA-cleared wearable device for acute and/or preventive migraine treatment. This study will evaluate the real-world efficacy and patient-reported outcomes of preventive REN use over 3 months in migraine patients.

Key Dates

First listed
Mar 23, 2026
Start date
Feb 20, 2026
Status verified
Mar 2026
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
332 participants (actual)
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)

FacilityCityStateZIPSite coordinators
Theranica Bio-Electronics IncBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By condition
Migraine
By specialty
Neurology
By research site
Theranica Bio-Electronics Inc· Bridgewater, NJ

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