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:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT05524493
Eligibility Criteria:
Inclusion Criteria:
Patients:
* Patient must be able to read and sign the informed consent form
* Stable prophylactic medication for 2 months prior to MRI
* At leat one of the two criteria applies:
* Patients diagnosed with migraine (with or without aura, episodic or chronic). Diagnosis is ensured by clinical interview (at least 8 weeks prior to MRI). Also, patients complete a migraine questionnaire (HARDSHIP) (at least 8 weeks before MRI). Migraine frequency ≥ 2 migraine attacks/month.
* Patients with drug resistent epilepsy accroding to ILAE crtieria
* Patients with diagnoses of Visual snow syndrome
Healthy participants;
* No migraine (validated by questionnaire) or epilepsy
* Participants must be able to read and sign the informed consent form
Exclusion Criteria:
* Treatment of migraine disease with Botox within \< 4 months before baseline and during the study period
* Pregnant or breastfeeding women
* Intention during the course of the trial to become pregnant
* Women with bilateral ovariectomy, with or without hysterectomy, and postmenopausal women (\>2 years of age) are not considered childbearing.
* Other clinically significant comorbidities (e.g., renal insufficiency, hepatic dysfunction, cardiovascular disease, etc.),
* Known or suspected noncompliance with the protocol, drug or alcohol abuse,
* Patient's inability to follow trial procedures, e.g., due to language problems, mental illness, dementia, etc.,
* Prior participation in the clinical trial
* Enrolment of the investigator, his/ her family members, employees and other dependent persons of the test personnel
* Metallic objects in the body (e.g., splinters, MR incompatible implants).
* Pacemaker
* Claustrophobia
* Obesity (body mass index \> 35 kg/m2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05524493
Study Brief:
Protocol Section:
NCT05524493