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, open-label design with within-subject comparison. Participants first complete a 28-day electronic diary (eDiary) baseline run-in period (weeks -4 to -1). Participants who log at least 4 migraine days and achieve at least 80% diary compliance (22 of 28 days) during the baseline period proceed to a 12-week intervention phase (weeks 1-12) with full program access. Participants continue daily eDiary throughout the intervention phase. The primary objective is to evaluate the reduction in Monthly Migraine Days (MMDs) from the 28-day baseline to the final 28 days of the intervention (weeks 9-12). Secondary objectives include assessments of headache impact, work productivity, acute pain relief, and migraine responder rates.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Hinge Health, Inc.
San Francisco, California, United States
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.
Time frame: From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)
50% Responder Rate
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 4, Week 8, Week 12
Proportion Achieving Acute Pain Relief at 2 Hours Post-Treatment
Time frame: During 12-week intervention phase
Proportion Achieving Acute Pain Freedom at 2 Hours Post-Treatment
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Time frame: During 12-week intervention phase