Transnasal Cooling for Migraine

A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine

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.

Study Overview

• Status: Terminated
• Conditions: Migraine; Migraine Without Aura; Migraine With Aura; Episodic Migraine
• Intervention / Treatment: Device: CoolStat active device; Device: CoolStat sham device

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health Neurosciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow treatment; 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.	Device: CoolStat active device; The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
Experimental: Low flow treatment; 15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.	Device: CoolStat active device; The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
Sham Comparator: Sham flow ambient air; 15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.	Device: CoolStat sham device; The CoolStat sham device will administer a sham flow of ambient air into the nostril.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the CoolStat treatment session.	2 hours
Tolerability of the CoolStat Device	Number of subjects who fail to complete the full treatment session	15 minutes
Safety of the CoolStat Device	Number of participants with device-related adverse events	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) immediately after the CoolStat treatment session.	0 minutes
Pain Relief	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 24 hours after the CoolStat treatment session without the use of rescue medication	24 hours
Pain Freedom	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the CoolStat treatment session without the use of rescue medication	2 hours
Pain Freedom	The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 24 hours after the CoolStat treatment session without the use of rescue medication.	24 hours
Relief From Migraine-associated Symptoms	The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.	2 hours
Freedom From Migraine-associated Symptoms	The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication	2 hours
Use of Rescue Medication	The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.	0 to 24 hours

Collaborators and Investigators

• Sponsor: CoolTech LLC
• Investigators: Principal Investigator: Nauman Tariq, MD, Atrium Health Neurosciences Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 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: P-224011-0040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes