Migraine Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older
• People who have a documented or clinically recognised history of episodic or chronic migraine (with or without aura) for at least 12 months, confirmed through medical records, pharmacy prescription history, or a validated screening tool
• People whose migraine symptoms match a specific short screening test (the ID-Migraine Screener), where at least 2 out of 3 questions about the past 3 months are answered "yes" — the questions ask whether migraines limited daily activities for more than one day, caused nausea or stomach sickness, or caused significant sensitivity to light
• People whose migraines first started at age 50 or younger
• People who experience at least 4 migraine days during the 28-day pre-study tracking period, as recorded in a study diary app
• People who complete the study diary on at least 22 out of 28 days during the pre-study tracking period (at least 80% of days)
• People who are either taking no preventive migraine medication, or have been on a stable dose of a traditional oral preventive migraine medication (such as topiramate, beta-blockers, or amitriptyline) for at least 90 days before the tracking period begins
• People who have been on a stable dose of a CGRP monoclonal antibody (such as Aimovig, Emgality, Ajovy, or Vyepti) or Botox for migraine prevention for at least 6 months before the tracking period begins
• People who are willing to keep their current migraine medications unchanged and not start any new treatments during the 12-week study period
• People who have enough physical mobility to take part in the exercise component of the program, with or without reasonable adjustments — people with significant mobility restrictions (such as wheelchair users) may still be considered after a safety review by a study doctor or physiotherapist
• People who have active commercial health insurance coverage through an employer, a commercial insurer, or an affiliated benefit partner that supports digital health programs
• People who live in the United States
• People who have a valid email address
• People who personally own a smartphone (iPhone running iOS 15 or later, or Android phone running Android 10 or later) with Bluetooth, app store access, and compatibility with the study diary app
• People who are able to understand the study and provide their voluntary agreement to participate

Who may not be able to join:

• People who have a cardiac pacemaker, implanted or wearable defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other active implanted electronic medical device
• People who have a metal implant in the head or neck (dental work is not included in this restriction)
• People who received nerve block injections above the eye (supraorbital) or infusion treatments for migraine within the 4 months before the tracking period starts
• People who have other primary or secondary headache disorders, such as cluster headaches, New Daily Persistent Headache, or post-traumatic headache (note: medication overuse headache does not exclude someone from joining)
• People with a history of major head or neck injuries, or a physical condition (such as severe cervical spine instability) that a study doctor considers would make the exercise component unsafe; or a history of major cardiovascular events such as stroke, irregular heart rhythm, or heart attack
• People with a history of serious migraine complications, such as a stroke caused by a migraine or a seizure triggered by migraine aura
• People currently experiencing fever, chills, or night sweats lasting five or more days without improvement
• People whose headache pattern has changed significantly — for example, headaches that are becoming much more severe or frequent, represent a new type of pain, wake them from sleep, or worsen with movement such as coughing, straining, or changing position
• People who have recently experienced changes in vision, mental status, sensation, or physical strength, or who have new jaw pain or neck stiffness
• People who have had unexplained significant weight loss in the past 3 months, or persistent weakness or numbness in the arms or legs in the past 3 months
• People with a known history of conditions that may affect the immune system
• People who have experienced a head injury in the past 2 weeks, or have been diagnosed with a spinal fracture or shoulder dislocation in the past 3 months
• People who have experienced any major trauma, fracture, or significant injury (such as a car accident or sports injury) in the past 3 months
• People who have had any major surgery in the past 3 months
• People who are unable to stand up from a chair without assistance (unless they use a wheelchair and have been cleared through a physiotherapist review)
• People who have had a fall related to balance, weakness, vision, or other physical limitations in the past 3 months
• People with a current diagnosis of epilepsy or an active cancer diagnosis, or a history of cancer within the past 5 years
• People with a cognitive or neurological condition (such as dementia or Parkinson's disease) that may interfere with participation in the study
• People with a currently unmanaged psychiatric condition (such as schizophrenia, substance use disorder, or severe depression or anxiety) that, in the opinion of the investigator, could prevent them from following study instructions
• People who are pregnant, planning to become pregnant during the study, or currently breastfeeding
• People who are currently living in an institution
• People who do not have sufficient English language proficiency to complete study procedures and online surveys
• People who have previously enrolled in any Hinge Health program or taken part in prior Hinge Health research studies
• People who currently own or have previously used an Enso device or other prescribed high-frequency electrical stimulation therapy for pain treatment
• People who have participated in another investigational study within the 30 days before screening
• People who plan to travel outside of the United States within the first month of enrollment
• Current employees or contractors of Hinge Health, Inc. or L&E Research, and their immediate family members

Important: Always verify eligibility with the trial site directly before applying.