RecruitingMigraineMigraine With AuraMigraine Without Aura
A Comprehensive Digital Care Program for Migraine Management
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This study evaluates the clinical effectiveness of the Enso for Migraine program, a comprehensive digital care program combining an FDA-cleared neuromodulation wearable device (Enso), personalized exercise therapy, and a dedicated care team, in reducing migraine frequency among adults with episodic or chronic migraine.
Sponsor: Hinge Health, Inc
You may qualify if…
- ✓ 18 years of age or older
- ✓ Documented or clinical history of episodic or chronic migraine (with or without aura) for at least 12 months, consistent with ICHD-3 criteria. Verification of diagnosis must be established using one or more of the following methods: participant-provided medical records, documented pharmacy prescription history, or validated diagnostic screening instruments.
- ✓ Passes ID-Migraine Screener with a score of 2 or more "yes" answers to the following question: During the last 3 months, did you experience any of the following with your migraines? (1) Your migraines limited your ability to complete your daily activities for more than one day; (2) You felt nauseated or sick to your stomach; (3) Light bothered you (a lot more than when you don't have migraines).
- ✓ Migraine onset occurred at age 50 years or younger
- ✓ Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
- ✓ At least 80% eDiary compliance (minimum of 22 out of 28 days) during the prospective baseline run-in period
- ✓ Currently on a stable dose of traditional oral migraine preventive medication (e.g., topiramate, beta-blockers, amitriptyline) for at least 90 days prior to the start of the 28-day baseline period, or taking no preventive medication
- ✓ Currently on a stable dose of CGRP monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy, Vyepti) or OnabotulinumtoxinA (Botox) for at least 180 days (6 months) prior to the start of the 28-day baseline period
You may not qualify if…
- ✕ Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
- ✕ Presence of a metal implant in the head or neck (excluding dental work)
- ✕ Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
- ✕ Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion
- ✕ History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and/or Study Physician, would make the exercise therapy component of the program unsafe; History of major cardiovascular events (e.g., stroke, arrhythmia, myocardial infarction)
- ✕ History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)
- ✕ Presence of fever, chills, or night sweats lasting five or more days and not improving
- ✕ Significant change in headache pattern, including headaches that are becoming much more severe or frequent, represent a new type of pain, wake the participant from sleep, or worsen with positional changes (e.g., coughing, bearing down, or changing position)
Where it's recruiting
California
San Francisco
Source: ClinicalTrials.gov · NCT07642414 · last updated 2026-06-16