Status:
ACTIVE_NOT_RECRUITING
Cooling to Alleviate Migraine #3
Lead Sponsor:
Mi-Helper, Inc.
Conditions:
Migraine With or Without Aura
Migraine
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment ...
Eligibility Criteria
Inclusion
- Age of 18 to 70 years, inclusive, of either sex at birth.
- Lives in the contiguous United States.
- Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
- Diagnosis of migraine with or without aura for at least 1 year.
- Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
- Migraine onset before 50 years of age, self-reported during screening.
- Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
Exclusion
- Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
- Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- Participant using any opioid medication at the time of screening.
- 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.
- Participant lives at an altitude of 2000 meters or more above sea level.
- Self-reported intolerance to intranasal therapy.
- Self-reported recurrent epistaxis or chronic rhinosinusitis.
- Self-reported sinus or intranasal surgery within the last 4 months of screening.
- Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
- Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
- Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
- Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
- 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.
- Participant with severe uncontrolled psychiatric conditions or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- 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.
- Participation in a previous clinical study with the Mi-Helper device.
- Participation in a migraine study or any other interventional clinical study within the3 months prior to screening.
- Participant has an uncontrolled medical issue at the time of screening.
- Any condition for which transnasal air flow would be contraindicated, as determined by the Principal Investigator (PI).
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06874361
Start Date
March 24 2025
End Date
December 15 2025
Last Update
December 10 2025
Active Locations (1)
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1
SPRIM Pro
Indian Harbour Beach, Florida, United States, 32937