Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

A Prospective, Double-blind, Sham-controlled, Randomized Two-part Adaptive Clinical Trial to Assess the Safety, Efficacy, Tolerability, and Optimal Dose of the Mi-Helper Device for Acute Treatment of Episodic Migraine in an at Home Setting.

This is a prospective, double-blind, sham-controlled, randomized two-part clinical trial with an adaptive design. 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.

This study will be conducted in two parts. The first part of this study aims to determine the most effective dose of Mi-Helper and the second part aims to evaluate the efficacy, safety, and tolerability of the most effective dose of the Mi-Helper device for the acute treatment of episodic migraine in adults.

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine; Migraine Without Aura; Migraine With Aura; Episodic Migraine
• Intervention / Treatment: Device: Mi-Helper

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joy Holland; Phone Number: 5702288140; Email: jholland@cooltechcorp.com
• Study Contact Backup: Name: Casey Hannan; Email: channan@cooltechcorp.co

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Recruiting
      • ObvioHealth
      • Contact: Prakash Limbachiya; Email: prakash.limbachiya@obviohealth.com
      • Principal Investigator: Parth Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (active treatment 1); 4 LPM of dehumidified air administered via Mi-Helper for 15 minutes	Device: Mi-Helper; The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.; Other Names: Mi-Helper transnasal cooling device
Experimental: Group II (active treatment 2); 6 LPM of dehumidified air administered via Mi-Helper for 15 minutes	Device: Mi-Helper; The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.; Other Names: Mi-Helper transnasal cooling device
Experimental: Group III (active treatment 3); 10 LPM of dehumidified air administered via Mi-Helper for 15 minutes	Device: Mi-Helper; The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.; Other Names: Mi-Helper transnasal cooling device
Sham Comparator: Group IV (sham treatment); 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes	Device: Mi-Helper; The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.; Other Names: Mi-Helper transnasal cooling device

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Use of rescue medication 2-24 post treatment.	24 hours
Participants belief of which treatment is received.	24 hours

Collaborators and Investigators

• Sponsor: CoolTech LLC
• Collaborators: ObvioHealth
• Investigators: Principal Investigator: Parth Shah, MD, ObvioHealth

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura; Migraine with Aura
• Other Study ID Numbers: COT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No