NCT02461459Active, not recruiting
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition, this study will be establishing infrastructure for the collection and storage of human bio-specimens, including genetic material, from TSC patients and their family members with ASD.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 205 (actual)
- First submitted
- 11 May 2015
- Start date
- May 2015
- Primary completion date
- Dec 2025
- Lead sponsor
- Boston Children's Hospital
- Diseases
- Autism
- NCT number
- NCT02461459
What you commit to
- Study type: Observational
- Participants enrolled: 205
- From May 2015 to the primary completion date, Dec 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment.
Other illness
- 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.
Age
- 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.
Other
- Unwilling or unable to comply with study procedures and assessments.
Who the study is looking for
- 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
Age in the registry: 18 months to - · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Texas at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California at Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.