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.
What are the risks and discomforts of the study?
A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.
What happens with the results of the study?
You will receive summary scores for the behavioral testing performed for your child and you will have an opportunity to discuss these results with a psychologist. If necessary, the psychologist will provide referrals for your child for early intervention services, or for a full clinical evaluation.
After all study data has been analyzed, families will be informed of the overall results.
Do participants receive pay, compensation or reimbursement?
There is no compensation for your participation in this study, however; there may be limited travel funding available.
Who should I contact for more information?
Darcy Krueger, MD, PhD
Tuberous Sclerosis Clinic
Department of Neurology