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.

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) 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
• Minimum of 4 migraine days during the 28-day baseline run-in period, as confirmed by the study eDiary
• At least 80% eDiary compliance (minimum of 22 out of 28 days) during the prospective baseline run-in period
• Currently on a stable dose of traditional oral migraine preventive medication (e.g., topiramate, beta-blockers, amitriptyline) for at least 90 days prior to the start of the 28-day baseline period, or taking no preventive medication
• Currently on a stable dose of CGRP monoclonal antibodies (e.g., Aimovig, Emgality, Ajovy, Vyepti) or OnabotulinumtoxinA (Botox) for at least 180 days (6 months) prior to the start of the 28-day baseline period
• Willingness to maintain current preventive and as-needed (acute) medication regimens (e.g., triptans, NSAIDs, or abortive gepants) and refrain from initiating any brand new pharmacological or clinical treatments (e.g., nerve blocks, Botox, or infusions) for the duration of the 12-week intervention period
• Sufficient physical mobility to engage with the exercise therapy component of the program, with or without reasonable accommodations; participants reporting significant mobility restrictions (e.g., wheelchair use) will be eligible pending a clinical safety review by a Study Physician or Physical Therapist
• Active commercial health insurance coverage (either as the primary policyholder or a covered dependent) through an employer-sponsored health plan, commercial health insurer, or an affiliated benefit partner eligible for digital health solution deployment
• US resident
• Has a valid email account
• Personal ownership of a smartphone (iOS 15 or later, or Android 10 or later) with Bluetooth capability, app store access, and compatibility with the eDiary
• Able to understand and provide voluntary informed consent

Exclusion criteria

• 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
• History of major head or neck injuries or any physical condition (e.g., severe cervical spine instability) that, in the opinion of the Principal Investigator and/or Study Physician, would make the exercise therapy component of the program unsafe; History of major cardiovascular events (e.g., stroke, arrhythmia, myocardial infarction)
• History of major migraine complications (e.g., migrainous infarction or aura-triggered seizure)
• Presence of fever, chills, or night sweats lasting five or more days and not improving
• Significant change in headache pattern, including headaches that are becoming much more severe or frequent, represent a new type of pain, wake the participant from sleep, or worsen with positional changes (e.g., coughing, bearing down, or changing position)
• Recent changes in vision, mental status, sensation, or strength; or new onset of jaw pain or neck stiffness
• Unexplained significant weight loss (past 3 months), or persistent weakness/numbness in the extremities (past 3 months)
• Known history of conditions that may compromise the immune system
• Head trauma within the past 2 weeks or diagnosis of a spinal fracture or shoulder dislocation within the past 3 months
• Any major trauma, fracture, or significant injury (e.g., car accident, sports injury) within the past 3 months
• Any major surgery within the past 3 months
• Inability to stand up from a chair without assistance (unless the participant utilizes a wheelchair and has been cleared via PT review)
• History of falling due to balance, weakness, vision, or other physical limitations within the past 3 months
• Current diagnosis of epilepsy or active malignancy (history of cancer within the last 5 years)
• Presence of a cognitive or neurological disorder (e.g., dementia, Parkinson's disease) that may interfere with study participation
• Currently unmanaged psychiatric disorder (e.g., schizophrenia, substance abuse, or severe major depressive disorder/anxiety) that, in the opinion of the investigator, could prevent compliance with study instructions
• Pregnant, planning to become pregnant during the study, or currently breastfeeding
• Currently institutionalized
• Insufficient proficiency with the English language to take part in study procedures or complete online surveys
• Current or previous enrollment in any Hinge Health Program or participation in prior Hinge Health research studies
• Current ownership or previous use of an Enso device or other prescribed high-frequency electrical stimulation therapy for the treatment of pain
• Participation in an investigational study within 30 days prior to screening
• Planned travel outside of the U.S. within the first month of enrollment
• Current employees or contractors of Hinge Health, Inc. or L&E Research, and their immediate family members