0 to 6 Month Olds with No History of Seizures Needed for Epilepsy and Tuberous Sclerosis Complex (TSC) Research Study
What is the purpose of this study?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about early changes in brain patterns and see if they could predict future seizures.
Information gained from this study will be used to better understand the brain pattern changes that happen before the onset of epilepsy as well as the time between those pattern changes and the start of seizures.
Who can participate?
Infants, up to 6 months old, with TSC and no history of seizures may be eligible to participate.
What is involved?
Your child will be in the research study until the age of 2 and have 1 screening visit and 8 study visits.
The following is a list of some of the procedures that will take place during the study:
- Physical and neurological exam
- Blood draw
- Daily seizure diary
- Video EEG (a test to measure the electrical activity of the brain)
- Developmental evaluations
What are the benefits?
Your child might not receive a direct medical benefit. However, the information gained from this study may help researchers identify brain pattern changes that could be early indicators of childhood epilepsy.
Will I get all the facts about the study?
As a parent interested in having your child participate, you 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.
Do participants receive pay, compensation or reimbursement?
Participants may be eligible to receive limited reimbursement for travel expenses.
Who should I contact for more information?
Darcy Krueger, MD, PhD
Tuberous Sclerosis Clinic
Department of Neurology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039