NCT07642414
A Comprehensive Digital Care Program for Migraine Management
Recruiting
NAAges 18+InterventionalTreatmentHinge Health, Inc
~140 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Neuromodulation Wearable DeviceMigraine Digital Care Program
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change in Monthly Migraine Days (MMDs)
Measured over From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Willingness to maintain current preventive and as-needed (acute) medication regimens (e.g., triptans, NSAIDs, or abortive gepants) and refrain from initiating any brand new pharmacological or clinical treatments (e.g., nerve blocks, Botox, or infusions) for the duration of the 12-week intervention period
Sufficient physical mobility to engage with the exercise therapy component of the program, with or without reasonable accommodations; participants reporting significant mobility restrictions (e.g., wheelchair use) will be eligible pending a clinical safety review by a Study Physician or Physical Therapist
Active commercial health insurance coverage (either as the primary policyholder or a covered dependent) through an employer-sponsored health plan, commercial health insurer, or an affiliated benefit partner eligible for digital health solution deployment
US resident
Has a valid email account
Personal ownership of a smartphone (iOS 15 or later, or Android 10 or later) with Bluetooth capability, app store access, and compatibility with the eDiary
Able to understand and provide voluntary informed consent
Exclusion
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)
Recent changes in vision, mental status, sensation, or strength; or new onset of jaw pain or neck stiffness
Unexplained significant weight loss (past 3 months), or persistent weakness/numbness in the extremities (past 3 months)
Known history of conditions that may compromise the immune system
Head trauma within the past 2 weeks or diagnosis of a spinal fracture or shoulder dislocation within the past 3 months
Any major trauma, fracture, or significant injury (e.g., car accident, sports injury) within the past 3 months
Any major surgery within the past 3 months
Inability to stand up from a chair without assistance (unless the participant utilizes a wheelchair and has been cleared via PT review)
History of falling due to balance, weakness, vision, or other physical limitations within the past 3 months
Current diagnosis of epilepsy or active malignancy (history of cancer within the last 5 years)
Presence of a cognitive or neurological disorder (e.g., dementia, Parkinson's disease) that may interfere with study participation
Currently unmanaged psychiatric disorder (e.g., schizophrenia, substance abuse, or severe major depressive disorder/anxiety) that, in the opinion of the investigator, could prevent compliance with study instructions
Pregnant, planning to become pregnant during the study, or currently breastfeeding
Currently institutionalized
Insufficient proficiency with the English language to take part in study procedures or complete online surveys
Current or previous enrollment in any Hinge Health Program or participation in prior Hinge Health research studies
Current ownership or previous use of an Enso device or other prescribed high-frequency electrical stimulation therapy for the treatment of pain
Participation in an investigational study within 30 days prior to screening
Planned travel outside of the U.S. within the first month of enrollment
Current employees or contractors of Hinge Health, Inc. or L\&E Research, and their immediate family members
What this trial measures
- Mean Change in Monthly Migraine Days (MMDs)From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
A migraine day is defined per ICHD-3 criteria as a calendar day with headache lasting at least 4 hours (untreated or unsuccessfully treated) with moderate-to-severe pain intensity, accompanied by nausea/vomiting or photophobia/phonophobia. Monthly Migraine Days are counted over a 28-day period using daily electronic diary data.