Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC)

Completed

Conditions studied: Tuberous Sclerosis Complex

In brief

The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis complex (TSC) for a new study on early markers of autism. The study is looking for early signs for autism in a population (TSC) where autism is common. The goal of this project is to use behavioral testing, MRI and EEG techniques to identify children at risk for developing autism starting at 3 months of age and continuing until 36 months of age. Throughout the study, the investigators will recommend Early Intervention services for any child who shows early signs of autism.

Key facts

Study ID

NCT01780441

Run by

Boston Children's Hospital

People needed

166

Starts

2013-01-01

Expected to finish

2020-12-01

Last updated by the study team

2021-02-04

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram.
• Age criteria: 3 months- 12 months of age at time of enrollment. For study purposes, 3 months is defined as ≥ 9 weeks, 1 day and 12 months is defined as ≤ 13.5 months.

You may not qualify if…

• Prematurity, defined as gestational age < 36 weeks at time of delivery
• Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment
• Is taking an mTOR inhibitor such as rapamycin, sirolimus, or everolimus (other than topical formulations) at the time of study enrollment
• Subependymal Giant Cell Astrocytoma requiring medical or surgical treatment at the time of study enrollment
• History of epilepsy surgery at the time of study enrollment
• Contraindications to MRI scanning, such as metal implants/non-compatible medical devices or medical conditions

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California at Los Angeles — Los Angeles, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• University of Texas at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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