Recruiting

Enso

Sponsor:

Hinge Health, Inc

Code:

NCT07642414

Conditions

Migraine

Migraine With Aura

Migraine Without Aura

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neuromodulation Wearable Device

Migraine Digital Care Program

Study Details

Brief summary:

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.

Conditions

Migraine

Migraine With Aura

Migraine Without Aura

Study ID

NCT07642414

Start date

Jun, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

140 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Digital Care Program for Migraine Management

Participants complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1) and, if eligible, receive 12 weeks of access to the digital care program (weeks 1-12). Participants continue daily eDiary throughout the intervention phase. The program combines the FDA-cleared neuromodulation wearable device for acute migraine treatment with a digital care program delivered via the Hinge Health app.

Interventions

Neuromodulation Wearable Device

The Neuromodulation Wearable Device is an FDA-cleared (510(k)) Class II neuromodulation wearable used for acute migraine treatment. Participants use the device to treat migraine attacks as needed during the 12-week intervention phase.

Migraine Digital Care Program

A comprehensive digital care program delivered via the Hinge Health app, consisting of: (1) guided exercise therapy playlists targeting migraine prevention through structured physical activity; (2) a dedicated care team including a licensed physical therapist and health coach supporting clinical progress, adherence, and behavioral modification; (3) guided breathing exercises for relaxation and stress reduction; (4) in-app migraine trigger tracking allowing participants to log lifestyle, dietary, environmental, and hormonal factors associated with their episodes; and (5) a migraine-specific education library covering triggers, lifestyle modifications, sleep hygiene, and pain management strategies.

Primary outcome measure

  • Mean Change in Monthly Migraine Days (MMDs) [ Time Frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total) ]

Central Contacts and Locations

Locations

Hinge Health, Inc.

Recruiting

San Francisco, California, United States, 94105

Contacts

Hinge Health

855 902-2777help@hingehealth.com

More Information

Sponsor

Hinge Health, Inc

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • migraine
  • transcutaneous electrical nerve stimulation
  • neuromodulation
  • digital health
  • exercise therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hinge Health, Inc on 2026-06-16.