Hinge Health, Inc
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.
The Enso for Migraine program is a comprehensive digital care intervention consisting of: (1) an FDA-cleared neuromodulation wearable device for acute migraine pain relief; (2) guided exercise therapy playlists for migraine prevention; (3) a dedicated care team including a licensed physical therapist and health coach accessible through the Hinge Health app; (4) guided breathing exercises for relaxation and stress reduction; and (5) an in-app migraine trigger tracking journal and education library supporting behavioral awareness and self-management. The study uses a prospective, single-arm, op…
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) Yo…
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.
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.
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