Evaluation of a Comprehensive Digital Care Program for Migraine: A Prospective, Single-Arm, Pilot Study
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.
• 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