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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT02185703
Eligibility Criteria:
Inclusion Criteria:
* Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders \[ICHD\]-III beta).
* History of 1 to 6 migraine attacks per month for at least 12 previous months.
* At least 50% of previous migraine attacks had moderate or severe pain intensity.
* History of at least 48 hours of freedom from headache between migraine attacks.
* The majority of the previous untreated migraine attacks lasted at least 8 hours.
* Migraine onset before the age of 50 years.
Exclusion Criteria:
* History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
* More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
* Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
* Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
* Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
* Pronounced anterior septal nasal deviation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02185703
Study Brief:
Protocol Section:
NCT02185703