A Comprehensive Digital Care Program for Migraine Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHinge Health, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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) Your migraines limited your ability to complete your daily activities for more than one day; (2) You felt nauseated or sick to your stomach; (3) Light bothered you (a lot more than when you don't have migraines).
Migraine onset occurred at age 50 years or younger
Disqualifiers
Presence of a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
Presence of a metal implant in the head or neck (excluding dental work)
Supraorbital nerve blocks or infusion treatments for migraine received within 4 months before the start of the baseline period
Presence of other primary or secondary headache disorders (e.g., cluster headache, New Daily Persistent Headache, or post-traumatic headache); Note: Medication Overuse Headache (MOH) is NOT an exclusion criterion
Trial design
Design model
Single group
Treatments tested in this trial
Neuromodulation Wearable Device
DeviceThe 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.
Migraine Digital Care Program
Other interventionA 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.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Digital Care Program for Migraine ManagementExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
Work Productivity and Activity Impairment (WPAI: Migraine)
Time frame
Baseline, Week 4, Week 8, Week 122
Patient Global Impression of Change (PGIC)
Time frame
Week 4, Week 8, Week 123
Acute Migraine Medication Utilization
Time frame
From the 28-day baseline run-in period to the final 28 days of the 12-week intervention (approximately 16 weeks total)Sponsors and contacts
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Source ClinicalTrials.gov