Evaluation of a Wearable Device for Acute Treatment of Migraines

Prior treatment

• Use of antipsychotic medication up to 3 months before study recruitment.
• Has a metal implant in the upper extremities or head.
• 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.

Other illness

• 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 history of major head or neck surgeries.

Other

• 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.
• Pregnant.
• 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.

• 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:
  • ID-Migraine pre-screening questions: i. How many headaches have participants experienced within the previous 3 months?
• 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.