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:
of medical family history
- Neuropsychological evaluation (IQ and communication,
socialization and other skills)
(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
- 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?
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.
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?
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Darcy Krueger, MD, PhD