RECRUITING

Cooling to Alleviate Migraine #3

Conditions

Migraine With or Without Aura Migraine Migraine Headache Neuromodulation Device Neuromodulation device Decentralized

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 of migraine in an at home setting. Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.

Official Title

A Prospective, Double-blind, Sham-controlled, Randomized Clinical Trial to Assess the Safety and Efficacy of the Mi-Helper Device for Acute Treatment of Migraine in an At Home Setting.

Quick Facts

Study Start:2025-03-24

Study Completion:2025-12-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06874361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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 uncontrolled psychiatric conditions 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).

Inclusion Criteria

Exclusion 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.

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 uncontrolled psychiatric conditions 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).

Contacts and Locations

Study Contact

Joy Holland, MPH

CONTACT

5702288140

jholland@cooltechcorp.com

Principal Investigator

Jessica Ailani, MD

PRINCIPAL_INVESTIGATOR

MedStar Georgetown Headache Center

Study Locations (Sites)

SPRIM Pro

Indian Harbour Beach, Florida, 32937

United States

Collaborators and Investigators

Sponsor: Mi-Helper, Inc.

Jessica Ailani, MD, PRINCIPAL_INVESTIGATOR, MedStar Georgetown Headache Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24

Study Completion Date2025-12-15

Study Record Updates

Study Start Date2025-03-24

Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

Neuromodulation
Device
Neuromodulation device
Decentralized

Additional Relevant MeSH Terms

Migraine With or Without Aura
Migraine
Migraine Headache