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
Qualifiers
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
Treatments tested in this trial
- Neuromodulation Wearable Device
- Migraine Digital Care Program
Treatment groups
140 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov