Clinical trial NCT06874361: Cooling to Alleviate Migraine #3
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine With or Without Aura
Migraine
Migraine Headache
Keywords: Neuromodulation
Device
Neuromodulation device
Decentralized
Lead sponsor: Mi-Helper, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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).

Primary outcomes:
measure: Pain Freedom at 2 Hours Post Treatment
timeFrame: 2 hours
measure: Incidence of Adverse Events
timeFrame: From treatment initiation through study exit (48 hours)
Secondary outcomes:
measure: Tolerability of the Mi-Helper Device
timeFrame: 2 hours
measure: Pain Relief at 2 Hours Post Treatment
timeFrame: 2 hours
measure: Sustained Pain Freedom at 24 Hours Post Treatment
timeFrame: 2-24 Hours
measure: Sustained Pain Relief at 24 Hours Post Treatment
timeFrame: 2-24 Hours
measure: Pain Relief Immediately Post Treatment
timeFrame: 0 minutes
measure: Freedom from Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
timeFrame: 2 hours
measure: Relief from Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
timeFrame: 2 hours
measure: Freedom from Most Bothersome Symptom (MBS) at Immediately Post Treatment
timeFrame: 0 minutes
measure: Relief from Most Bothersome Symptom (MBS) Immediately Post Treatment
timeFrame: 0 hours
measure: Freedom from Nausea Immediately Post Treatment
timeFrame: 0 hours
measure: Freedom from Photophobia Immediately Post Treatment
timeFrame: 0 Hours
measure: Freedom from Phonophobia Immediately Post Treatment
timeFrame: 0 hours
measure: Freedom from Nausea at 2 Hours Post Treatment
timeFrame: 2 Hours
measure: Freedom from Photophobia at 2 Hours Post Treatment
timeFrame: 2 Hours
measure: Freedom from Phonophobia at 2 Hours Post Treatment
timeFrame: 2 Hours
Other outcomes:
Locations:
city: Indian Harbour Beach
country: United States
facility: SPRIM Pro
state: Florida
Study officials:
affiliation: MedStar Georgetown Headache Center
name: Jessica Ailani, MD
role: PRINCIPAL_INVESTIGATOR
References: