Transnasal Cooling for Migraine
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 21-008210
NCT ID: NCT04936061
Sponsor Protocol Number: P-224011-0040
About this study
The purpose of this study is 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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).
- Patient is between 18 and 80 years of age.
- Patient experiences 2 to 8 migraine attacks per month.
- Patient is in good reported general health, with no fever (< 38.3C/101F).
- Patient has had diagnosis of migraine with or without aura over at least 1 year.
- Migraine onset before 50 years of age.
- Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
- Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
- Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
- Has difficulty distinguishing his or her migraine attacks from tension-type headaches.
- Patient has uncontrolled hypertension.
- Patient has a fever (≥ 38.3C / 101F).
- Patient has used opioid medication or barbiturates in the past month.
- Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
- Patient has 15 or more headache days per month.
- 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).
- Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
- Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
- Recurrent epistaxis or chronic rhinosinusitis.
- Recent facial trauma, sinus or intranasal surgery within the last 4 months.
- Known or suspected pregnancy.
- Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amaal Starling, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available