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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT02461420
Eligibility Criteria:
Inclusion Criteria:
* Individuals older than 18 months of age with pathogenic deletions or mutations of the SHANK3 gene
* English speaking individuals
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 over 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:
NCT02461420
Study Brief:
Protocol Section:
NCT02461420