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RECRUITING
NCT07642414
NA

A Comprehensive Digital Care Program for Migraine Management

Sponsor: Hinge Health, Inc

View on ClinicalTrials.gov

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.

Official title: Evaluation of a Comprehensive Digital Care Program for Migraine: A Prospective, Single-Arm, Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-06

Completion Date

2026-11

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DEVICE

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.

OTHER

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.

Locations (1)

Hinge Health, Inc.

San Francisco, California, United States