A Comprehensive Digital Care Program for Migraine Management

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.