Transnasal Cooling for Migraine

Overview

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 Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Amaal Starling, M.D.

Open for enrollment

Contact information:

Stephanie Ruiz Morales

(480) 301-6198

RuizMorales.Stephanie@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20522960

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