Cooling to Alleviate Migraine #3

NCT06874361 | Completed Results FDA Device

• 1 other identifier: COT-004
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine With or Without Aura; Migraine; Migraine Headache

Keywords

Neuromodulation; Device; Neuromodulation device; Decentralized

Outcome Measures

Primary Outcomes (1)

• Pain Freedom at 2 Hours Post Treatment

  Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used)

  2 hours

Secondary Outcomes (4)

• Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment

  2 hours

• Sustained Pain Freedom at 24 Hours Post Treatment

  2-24 Hours

• Pain Relief at 2 Hours Post Treatment

  2 hours

• Participants' Global Impression of Acute Treatment Effect

  24 Hours

Other Outcomes (12)

• Rescue Medication Use

  2 Hours

• Pain Freedom Immediately Post Treatment

  0 Hours

• Pain Relief Immediately Post Treatment

  0 minutes

Study Arms (2)

Group I (active treatment)

EXPERIMENTAL

10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes

Device: Mi-Helper

Group II (sham)

SHAM COMPARATOR

2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes

Device: Mi-Helper

Interventions

Mi-Helper DEVICE

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.

Group I (active treatment); Group II (sham)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mi-Helper, Inc.: lead

Study Sites (1)

SPRIM Pro

Indian Harbour Beach, Florida, 32937, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Steve Schaefer, CEO
• Organization: Mi-Helper, Inc.

sschaefer@cooltechcorp.com

443-845-9780

Study Officials

• Jessica Ailani, MD

  MedStar Georgetown Headache Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 13, 2025
• Study Start: March 24, 2025
• Primary Completion: October 29, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available within 6 months of the study's conclusion and will remain available for at least 3 years.
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve results in line with the proposed outcomes will be able to obtain IPD.

Locations

US (1)