Transnasal Cooling for Migraine

NCT ID: NCT04936061

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-14
• Study Completion Date: 2022-09-30

Brief Summary

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.

Conditions

Migraine; Episodic Migraine; Migraine With Aura; Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High flow treatment

15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.

Group Type: EXPERIMENTAL

CoolStat active device

Intervention Type: DEVICE

The CoolStat active device will administer a therapeutic flow of dry air into the nostril.

Low flow treatment

15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.

Group Type: EXPERIMENTAL

CoolStat active device

Intervention Type: DEVICE

The CoolStat active device will administer a therapeutic flow of dry air into the nostril.

Sham flow ambient air

15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.

Group Type: SHAM_COMPARATOR

CoolStat sham device

Intervention Type: DEVICE

The CoolStat sham device will administer a sham flow of ambient air into the nostril.

Interventions

CoolStat active device

The CoolStat active device will administer a therapeutic flow of dry air into the nostril.

Intervention Type: DEVICE

CoolStat sham device

The CoolStat sham device will administer a sham flow of ambient air into the nostril.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).

2. Patient is between 18 and 80 years of age.

3. Patient experiences 2 to 8 migraine attacks per month.

4. Patient is in good reported general health, with no fever (<38.3C/101F).

5. Patient has had diagnosis of migraine with or without aura over at least 1 year.

6. Migraine onset before 50 years of age.

7. Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.

8. Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.

9. Migraine pain severity of Grade 2 or Grade 3 on day of treatment.

10. Provision of signed and dated informed consent form.

11. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria

1. has difficulty distinguishing his or her migraine attacks from tension-type headaches

2. Patient has uncontrolled hypertension.

3. Patient has a fever (≥38.3C / 101F).

4. Patient has used opioid medication or barbiturates in the past month.

5. Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).

6. Patient has 15 or more headache days per month.

7. Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).

8. Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.

9. Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.

10. Recurrent epistaxis or chronic rhinosinusitis.

11. Recent facial trauma, sinus or intranasal surgery within the last 4 months.

12. Known or suspected pregnancy.

13. Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CoolTech LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nauman Tariq, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Neurosciences Institute

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Michigan State University

East Lansing, Michigan, United States

Atrium Health Neurosciences Institute

Charlotte, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P-224011-0040

Identifier Type: -

Identifier Source: org_study_id