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 range
18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety/Adverse Events
Timeframe: Pre-treatment, 1, 2, and 24 hours post-treatment.