Transnasal Cooling for Migraine

Not Applicable

Terminated

• Conditions: Migraine; Episodic Migraine; Migraine Without Aura; Migraine With Aura
• Interventions: Device: CoolStat sham device; Device: CoolStat active device

• Registration Number: NCT04936061
• Lead Sponsor: CoolTech LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-23
• Study Start: 2021-10-14
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30
• Results First Submitted: 2023-06-29
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Results First Posted: 2023-09-29
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham flow ambient air	CoolStat sham device	15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.
Low flow treatment	CoolStat active device	15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
High flow treatment	CoolStat active device	15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.

Primary Outcome Measures

Name	Time	Method
Pain Relief	2 hours	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.
Tolerability of the CoolStat Device	15 minutes	Number of subjects who fail to complete the full treatment session
Safety of the CoolStat Device	24 hours	Number of participants with device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Pain Relief	24 hours	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
Pain Freedom	24 hours	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.
Relief From Migraine-associated Symptoms	2 hours	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.
Freedom From Migraine-associated Symptoms	2 hours	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
Use of Rescue Medication	0 to 24 hours	The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.

Trial Locations

Locations (3)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Atrium Health Neurosciences Institute; 🇺🇸 Charlotte, North Carolina, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States