Evaluation of a Wearable Device for Acute Treatment of Migraines

Inclusion 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:
• •a. 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.