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 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT02098759
Eligibility Criteria:
Inclusion criteria
Inclusion criteria for TSC patients:
* male or female infants with a definite diagnosis of TSC (Roach criteria; Roach 1998 or DNA confirmed),
* age up to 4 months at the moment of enrolment,
* no clinical seizures seen by caregivers or on baseline videoEEG recording,
* written informed consent of caregivers. It is possible to give consent for the observational part of the study only. In this case, the child will not enter the randomized part of the study.
Inclusion criteria for the control group:
* male or female infants who have undergone routine MRI for reasons other than epilepsy and brain tumor or cortical defects,
* age up to 24 months at the moment of study entry,
* written informed consent of caregivers. Exclusion criteria
Exclusion criteria for TSC patients:
* any type of seizures observed till baseline visit,
* antiepileptic treatment at or prior to study entry,
* contraindications to MRI,
* any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures.
Exclusion criteria for the control group:
* any sign or symptom suggesting TSC diagnosis,
* any type of seizures observed at study entry,
* antiepileptic treatment at study entry,
* history of seizures, with the exception of febrile seizures,
* any severe and/or uncontrolled medical condition that is considered by the investigator as possibly affecting the EPISTOP analyses or procedures.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Months
Study:
NCT02098759
Study Brief:
Protocol Section:
NCT02098759