Clinical Trials

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.