Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Not Applicable

Active, not recruiting

• Conditions: Migraine Without Aura; Migraine; Migraine With Aura; Episodic Migraine
• Interventions: Device: Mi-Helper

• Registration Number: NCT06051604
• Lead Sponsor: CoolTech LLC

Brief Summary

This is a prospective, double-blind, sham-controlled, randomized clinical trial . This study aims to assess the efficacy, safety, tolerability, and the optimal dose of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting.

Adults aged 18 years to 65 years old with a diagnosis of episodic migraine (with or without aura) for at least one year (self-reported) will be recruited for this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-25
• Study Start: 2023-11-15
• Primary Completion: 2024-06-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. Age of 18 to 65 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 informed consent.
4. Individual has had a diagnosis of episodic migraine with or without aura over at least 1 year, self-reported during screening.
5. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
6. Individual is in good reported general health at the time of screening.
7. Migraine onset before 50 years of age, self-reported during screening.
8. Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.
9. Stated willingness to comply with all study procedures and availability for the duration of the study.
10. 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 tension-type 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, supraorbital or occipital nerve blocks 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. Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (sham)	Mi-Helper	2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Group II (active treatment 1)	Mi-Helper	4 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Group III (active treatment 2)	Mi-Helper	6 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Group IV (active treatment 3)	Mi-Helper	10 LPM of dehumidified air administered via Mi-Helper for 15 minutes

Primary Outcome Measures

Name	Time	Method
Pain relief at 2 hours post treatment	2 hours	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Safety of the Mi-Helper device	24 hours	Measured by incidence of adverse events
Tolerability of the Mi-Helper device	15 minutes	Based on percent of participants who fail to complete the full treatment session

Secondary Outcome Measures

Name	Time	Method
Pain relief immediately post treatment	0 minutes	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Pain relief at 24 hours post treatment	24 hours	From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Pain freedom at 2 hours post treatment	2 hours	A reduction of mild, moderate or severe pain at baseline to no pain.
Pain freedom at 24 hours post treatment	24 hours	A reduction of mild, moderate or severe pain at baseline to no pain.
Freedom from MBS immediately post treatment	0 minutes	A reduction of mild, moderate or severe pain at baseline to none.
Freedom from MBS at 24 hours post treatment	24 hours	A reduction of mild, moderate or severe pain at baseline to none.
Relief from most bothersome symptom (MBS) immediately post treatment	0 minutes	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale
Pain freedom immediately post treatment	0 minutes	A reduction of mild, moderate or severe pain at baseline to no pain.
Freedom from MBS at 2 hours post treatment	2 hours	A reduction of mild, moderate or severe pain at baseline to none.
Relief from MBS at 2 hours post treatment	2 hours	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale
Relief from MBS at 24 hours post treatment	24 hours	From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale

Trial Locations

Locations (1)

ObvioHealth; 🇺🇸 New York, New York, United States