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A Comprehensive Digital Care Program for Migraine Management

NCT07642414 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-06-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hinge Health, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-10-31
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07642414 on ClinicalTrials.gov