Evaluation of a Wearable Device for Acute Treatment of Migraines

Eligibility Criteria

• * Diagnosis of migraine with or without aura, identified via participant-provided medical records.
• * Average migraine pain is 4 or more on the 0-10 Numerical Rating Scale (NRS) for pain.
• * Passes ID-Migraine pre-screening questions and has ID-Migraine score ≥ 2:
• * Needs to be ≥ 6 headaches ii. Do the headaches that participants experience limit the ability to work, study, or enjoy life, or does the participant wish to speak with a healthcare professional about the headaches? (yes / no)
• * Participant needs to respond "yes" b. ID-Migraine questions: i. Over the last 3 months, did participants have any of the following with headaches?
• * Felt nauseated or sick to stomach (yes \[1\] / no \[0\])
• * Light bothered them (a lot more than when headaches are not present)? (yes \[1\] / no \[0\])
• * Headaches limited the ability to work, study, or do what needed to be done? (yes \[1\] / no \[0\])
• * Able to understand and provide informed consent.
• * Age 18 and older.
• * US resident.
• * Has experienced migraines for at least 1 year prior to recruitment.
• * Onset of migraines occurred at age 50 years or younger.
• * Average of at least 2 migraines per month of moderate to severe intensity.
• * Is either on a) no medications or b) a stable dose of migraine-preventative medication for at least 2 months prior to recruitment.
• * Willing to refrain from altering preventive medication for migraines (or from using botox), commit to using Enso as the first-line treatment, and wait at least 2 hours after Enso treatment before using any additional abortives during the study period.
• * Participants must own an iPhone with iOS 15 or newer, or an Android phone with Android 9 or newer, with Bluetooth capability and access to either the Apple App Store (for iOS devices) or Google Play Store (for Android devices).
• * Has an email account.
• * Typical migraine pain is \< 4 out of 10 on the 0-10 NRS.
• * Currently institutionalized.
• * Currently is or has ever been a Hinge Health member.
• * Use of antipsychotic medication up to 3 months before study recruitment.
• * Diagnosis of cancer/malignant tumors in the last 5 years.
• * Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol.
• * Has epilepsy.
• * Has a history of major cardiovascular events such as strokes, arrhythmias, or myocardial infarction.
• * Has a history of major migraine complications such as migrainous infarction or migraine aura-triggered seizure
• * Diagnosed with secondary headache disorders including medication overuse headaches
• * History of opioid, alcohol, or drug abuse in the last 1 year.
• * Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device.
• * Has a metal implant in the upper extremities or head.
• * Has a history of major head or neck surgeries.
• * Pregnant.
• * Currently participating or has participated in a study with an investigational compound or device within the last 30 days before the screening visit.
• * Currently using a TENS device to treat migraines.
• * Received supraorbital nerve blocks or Botox treatment within 4 months prior to recruitment.
• * Insufficient proficiency with the English language to take part in study procedures or complete online surveys.
• * Planning to travel outside of the US within three months after consenting to the study.