A Comprehensive Digital Care Program for Migraine Management

NCT07642414 | Recruiting FDA Device

• 1 other identifier: HH-2026-COM-MIG
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean Change in Monthly Migraine Days (MMDs)

  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.

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

Secondary Outcomes (7)

• 50% Responder Rate

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

• Mean Change in Monthly Headache Days (MHDs)

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

• Mean Change in Migraine Pain Intensity (NRS)

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

• Mean Change in Average Migraine Attack Duration

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

• Mean Change in Headache Impact Test-6 (HIT-6) Score

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (3)

• Work Productivity and Activity Impairment (WPAI: Migraine)

  Baseline, Week 4, Week 8, Week 12

• Patient Global Impression of Change (PGIC)

  Week 4, Week 8, Week 12

• Acute Migraine Medication Utilization

  From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)

Study Arms (1)

Digital Care Program for Migraine Management

EXPERIMENTAL

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.

Device: Neuromodulation Wearable Device; Other: Migraine Digital Care Program

Interventions

Neuromodulation Wearable Device 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.

Digital Care Program for Migraine Management

Migraine Digital Care Program OTHER

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.

Digital Care Program for Migraine Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Hinge Health, Inc: lead

Study Sites (1)

Hinge Health, Inc.

San Francisco, California, 94105, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jeffrey Krauss, MD

  Hinge Health, Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin James

CONTACT

855-902-2777; justin.james@hingehealth.com

Folasade Phillips, MPH

CONTACT

folasade.phillips@hingehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)