Evaluation of a Wearable Device for Acute Treatment of Migraines

Inclusion Criteria:

• Diagnosis of migraine with or without aura, identified via participant-providedmedical records.

• Average migraine pain is 4 or more on the 0-10 Numerical Rating Scale (NRS) forpain.

• Passes ID-Migraine pre-screening questions and has ID-Migraine score ≥ 2: a. ID-Migraine pre-screening questions: i. How many headaches have participantsexperienced within the previous 3 months?

• Needs to be ≥ 6 headaches ii. Do the headaches that participants experience limitthe ability to work, study, or enjoy life, or does the participant wish to speakwith a healthcare professional about the headaches? (yes / no)

• Participant needs to respond "yes" b. ID-Migraine questions: i. Over the last 3months, 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-preventativemedication for at least 2 months prior to recruitment.

• Willing to refrain from altering preventive medication for migraines (or from usingbotox), commit to using Enso as the first-line treatment, and wait at least 2 hoursafter 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 withAndroid 9 or newer, with Bluetooth capability and access to either the Apple AppStore (for iOS devices) or Google Play Store (for Android devices).

• Has an email account.

Exclusion Criteria:

• 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 thesubject from complying with the requirements of the protocol.

• Has epilepsy.

• Has a history of major cardiovascular events such as strokes, arrhythmias, ormyocardial infarction.

• Has a history of major migraine complications such as migrainous infarction ormigraine 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 investigationalcompound 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 torecruitment.

• Insufficient proficiency with the English language to take part in study proceduresor complete online surveys.

• Planning to travel outside of the US within three months after consenting to thestudy.