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 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT02461459
Eligibility Criteria:
Inclusion Criteria:
* Meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, and echocardiogram.
* Age criteria: over 18 months of age at time of enrollment.
* Is diagnosed or suspected to have ASD and/or ID.
* Primary communicative language is English
Exclusion Criteria:
* Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment.
* For subjects involved in imaging biomarker assessment: contraindications to 3T MRI scanning, such as metal implants/non-compatible medical devices or medical conditions, including vagus nerve stimulator.
* For subjects involved in EEG/ERP biomarker assessment: contraindications to EEG/ERP, such as uncooperative or destructive behaviors preventing lead placement or capture by ERP/VEP equipment. Under age 2 or above age 11 at the time of enrollment.
* Unwilling or unable to comply with study procedures and assessments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Study:
NCT02461459
Study Brief:
Protocol Section:
NCT02461459