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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT03547050
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Rolandic Epilepsy in accordance with the following international criteria:
* Age of first afebrile seizure 3-12 years
* Seizures comprising focal sensorimotor seizures affecting the vocal tract and face, with or without involvement of the arm
* Predominant sleep-related seizures
* EEG interictal centro-temporal spikes with normal background
2. Current age 6-25 years
Exclusion Criteria:
1. No history of focal seizure
2. Normal EEG or abnormal background features on EEG
3. Known structural causes (stroke, tuberous sclerosis, infection, post-infectious or metabolic)
4. Primary diagnosis of autism or global learning disability
5. Focal central neurological deficit on clinical exam,
6. Unable to provide informed consent
7. Unable to provide blood sample
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
25 Years
Study:
NCT03547050
Study Brief:
Protocol Section:
NCT03547050