Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT04936061
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04936061
Study Brief:
Protocol Section:
NCT04936061