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Find Another Clinical Study

3 to 9 Month Olds with Tuberous Sclerosis Complex (TSC) Needed for Research Study

What is the purpose of this study?

The purpose of this research study, sometimes known as a clinical trial or clinical study, is to look for early signs of autism in children with Tuberous Sclerosis Complex (TSC), a genetic disorder where autism is common.

Who can participate?

Infants 3 to 9 months old who are diagnosed with TSC may be eligible to participate.

What is involved?

After the initial screening visit, your child will be in the research study for about 2 to 3 years and have a total of 7 study visits. Study visits will vary in length based on your child’s age, but generally be a few hours in time.

The following is a list of some of the procedures that will take place during the study:

Review of medical family history
Physical exam
Neuropsychological evaluation (IQ and communication, socialization and other skills)
MRI (a way to take pictures of the body using a large magnet, radio waves and a computer)
Video EEG (a test to measure the electrical activity of the brain)
Testing for autism
Parent interviews/questionnaires
Blood draws
Optional genetic testing

What are the benefits?

Your child might not receive a direct medical benefit. However, the information gained from this study may benefit individuals with TSC in the future.

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.