A Comprehensive Digital Care Program for Migraine Management

Part of paid clinical trials in San Francisco, California.

Sponsor
Hinge Health, Inc
Study ID
NCT07642414
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Hinge Health, Inc.San FranciscoCalifornia94105-

Find similar trials in San Francisco, CA

By condition
Migraine
By specialty
Neurology
By research site
Hinge Health, Inc.· San Francisco, CA

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