Evaluation of a Wearable Device for Acute Treatment of Migraines (NCT07015125) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Wearable Device for Acute Treatment of Migraines
United States160 participantsStarted 2025-06-09
Plain-language summary
The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the head and neck to relieve migraine pain. To measure efficacy, investigators will compare how measured outcomes resulting from active stimulation with this device compare to those of sham treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Safety/Adverse Events
Timeframe: Pre-treatment, 1, 2, and 24 hours post-treatment.