Mi-Helper for Migraine

(CALM3 Trial)

Overseen By Joy Holland, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mi-Helper, Inc.

Must not be taking: Opioids, Barbiturates

Disqualifiers: Chronic pain, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Mi-Helper device, which uses cooled air through the nose, can safely and effectively treat migraines at home. Participants will receive either the active treatment with dehumidified air or a sham treatment with regular air. It targets individuals who have experienced migraines, with or without visual symptoms, for at least a year and have between 2 to 8 migraine attacks per month. This trial excludes those unable to distinguish migraine attacks from other headaches or those who have had recent sinus surgery. As an unphased trial, it offers participants the opportunity to contribute to innovative migraine treatment research.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that your migraine preventive medication has not changed for 4 weeks before joining. If you are using opioid medications, you cannot participate.

What prior data suggests that the Mi-Helper transnasal cooling device is safe for treating migraines?

Research has shown that the Mi-Helper transnasal cooling device is generally safe and well-tolerated for treating migraines. Studies have found that blowing cooled room air through the nose can effectively and safely ease migraine pain. Additional evidence supports that the Mi-Helper is non-invasive, meaning it doesn't require insertion into the body, enhancing its safety. Users can operate the device themselves, indicating it is easy and safe for daily use. No reports of serious side effects have emerged, suggesting this treatment is likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mi-Helper for migraines because it offers a novel approach to treatment using a simple yet innovative delivery method. Unlike standard migraine treatments that often rely on medications like triptans or anti-inflammatories, Mi-Helper delivers dehumidified air at a high flow rate directly through a device. This method could potentially offer quick relief without the side effects associated with drugs. The idea of using air therapy is fresh and could open up new avenues for managing migraines, particularly for those who may not respond well to existing medications.

What evidence suggests that the Mi-Helper device is effective for treating migraines?

Studies have shown that the Mi-Helper transnasal cooling device can effectively relieve migraine pain. In earlier research, 47% of patients using the device reported being pain-free two hours after treatment, and 71% experienced significant pain relief without needing extra medication. In this trial, participants in the active treatment group will receive 10 liters per minute of dehumidified air via Mi-Helper for 15 minutes. The device blows dry, cool air through the nose, reducing headache symptoms. This evidence supports Mi-Helper's potential effectiveness in treating migraines at home. ^{1 2 3 4 6}

Who Is on the Research Team?

Jessica Ailani, MD

Principal Investigator

MedStar Georgetown Headache Center

Are You a Good Fit for This Trial?

Adults aged 18 to 70 with a migraine diagnosis for at least one year can participate. The trial is designed for those who experience migraines, with or without aura, and are seeking an acute treatment that can be used at home.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study

My migraines started before I was 50.

Lives in the contiguous United States

Exclusion Criteria

Known or suspected pregnancy

I have 15 or more headache days each month.

I haven't had Botox, barbiturates, or certain injections in my head or neck in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Mi-Helper transnasal cooling device or a sham comparator for acute treatment of migraine

48 hours

At-home treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Mi-Helper

Trial Overview The Mi-Helper device, which provides transnasal cooling, is being tested to see if it's safe and effective in treating migraines when used at home. This study compares the real device to a sham (fake) version in a randomized setup where neither participants nor researchers know who gets which until after the results.

How Is the Trial Designed?

Group I: Group I (active treatment) Experimental Treatment 1 Intervention

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

Group II: Group II (sham) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Mi-Helper, Inc.

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

Rimegepant significantly improves outcomes for migraine patients, including freedom from pain and pain relief at 2 hours, with odds ratios indicating strong efficacy compared to placebo.

The treatment shows sustained benefits at 24 hours and does not appear to increase the risk of adverse events, suggesting it is a safe option for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. Yang, C., Zhang, Y.[2023]

This review emphasizes the importance of understanding the safety profiles of common acute migraine treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergot alkaloids, antiemetics, and newer options like gepants and ditans.

It provides strategies to mitigate risks, particularly cardiovascular and gastrointestinal concerns, and highlights the need for clinicians to balance efficacy with safety when selecting migraine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments. Orlova, YY., Mehla, S., Chua, AL.[2022]

The study involving 44 migraine patients demonstrated that online digital assistance (ODA) is feasible and well-accepted as a supportive tool for behavioral training (BT), with minimal technical issues and positive participant feedback.

However, the addition of ODA did not lead to significantly better outcomes in terms of migraine attack frequency or quality of life compared to those who only received BT, indicating that while ODA is useful, its effectiveness in enhancing BT results remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and preliminary effects of online digital assistance (ODA) for behavioral attack prevention in migraine. Kleiboer, A., Sorbi, M., Mérelle, S., et al.[2015]

Onabotulinumtoxin A is an effective treatment for chronic migraine, approved since 2010, and works by targeting the release of neurotransmitters and neuropeptides involved in headache mechanisms.

While onabotulinumtoxin A is associated with more treatment-related adverse events than a placebo, it has fewer side effects compared to the oral medication topiramate, indicating a relatively favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Corasaniti, MT., Bagetta, G., Nicotera, P., et al.[2023]

Citations

1. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/transnasal-evaporative-cooling-effective-for-acute-treatment-of-migraine-pain

Transnasal evaporative cooling effective for migraine pain Key results. A statistically significantly higher percentage of participants who used the Mi-Helper at 10 LPM were pain-free at two hours ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06051604

Mi-Helper Transnasal Cooling for Acute Treatment of ... This is a prospective, double-blind, sham-controlled, randomized clinical trial . This study aims to assess the efficacy, safety, tolerability, ...

3. vjneurology.com vjneurology.com/video/4tcjjumeins-the-efficacy-and-safety-of-the-mi-helper-transnasal-cooling-device-for-the-treatment-of-migraine/

AAN 2025 | The efficacy and safety of the Mi-Helper ... The Mi-Helper study showed significant pain relief and freedom from pain recurrence, with 47% of patients reporting pain freedom at two hours and 71% reporting ...

4. mihelper.com mihelper.com/blog-post-title/

Transnasal Evaporative Cooling Device for Migraine Results · 88% of the 6LPM group had pain relief at 2hrs without rescue medication (woRM). · 44% of the 6LPM group had pain freedom at 2hrs woRM.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06874361

NCT06874361 | Cooling to Alleviate Migraine #3 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 ...

6. obviohealth.com obviohealth.com/resources/pioneering-trial-on-the-device-treatment-of-migraine

ObvioHealth to Conduct a Pioneering Decentralized ... Mi-Helper has been developed to meet a massive unmet need for effective, targeted, and drug-free pain management of migraines, a condition which ...