Cooling to Alleviate Migraine #3

Launched by MI-HELPER, INC. · Mar 11, 2025

Keywords

ClinConnect Summary

The Cooling to Alleviate Migraine #3 trial is studying a device called the Mi-Helper, which cools the nasal passages, to see if it can help reduce migraine headaches when used at home. The trial is looking for adults aged 18 to 70 who have been diagnosed with migraines for at least a year and typically experience two to eight migraine attacks each month. Eligible participants must have a smartphone and an internet connection to help track their migraines and participate in the study.

If you join the trial, you will be randomly assigned to use either the Mi-Helper device or a placebo (a device that doesn’t actually work) without knowing which one you have. This helps ensure that the results are fair and accurate. Participants will be monitored to see how well the device works in relieving migraine pain and whether it is safe to use. Before enrolling, you'll need to meet certain criteria and may not be eligible if you have specific health conditions or are currently taking certain medications. This trial is not yet recruiting, so keep an eye out for updates if you think you might be interested!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age of 18 to 70 years, inclusive, of either sex at birth.
• • 2. Lives in the contiguous United States.
• • 3. Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
• • 4. Diagnosis of migraine with or without aura for at least 1 year.
• • 5. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
• • 6. Migraine onset before 50 years of age, self-reported during screening.
• • 7. Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
• • 8. Stated willingness to comply with all study procedures and availability for the duration of the study.
• • 9. Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
• Exclusion Criteria:
• • 1. Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
• • 2. Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
• • 3. Participant using any opioid medication at the time of screening.
• • 4. Participant has received Botox treatment, barbiturates, SPG block, nerve blocks or trigger point injections in the head or neck within the last 4 weeks of screening.
• • 5. Participant lives at an altitude of 2000 meters or more above sea level.
• • 6. Self-reported intolerance to intranasal therapy.
• • 7. Self-reported recurrent epistaxis or chronic rhinosinusitis.
• • 8. Self-reported sinus or intranasal surgery within the last 4 months of screening.
• • 9. Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
• • 10. Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
• • 11. Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
• • 12. Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
• • 13. Participant with active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or Complex Regional Pain Syndrome (CRPS); or other pain syndrome like trigeminal neuralgia.
• • 14. Participant with severe psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
• • 15. Failure to adhere to or inability to complete Study App inputs and onboarding activities during the screening period. Participants who are not adherent during the screening period are not eligible for study entry.
• • 16. Participation in a previous clinical study with the Mi-Helper device.
• • 17. Participation in a migraine study or any other interventional clinical study within the3 months prior to screening.
• • 18. Participant has an uncontrolled medical issue at the time of screening.
• • 19. Any condition for which transnasal air flow would be contraindicated, as determined by the Principal Investigator (PI).