Clinical Trials / Research Studies
Healthy Children Ages 8 to 12 Years Old Needed for a Research Study
Why are we doing this research?
Cincinnati Children's is conducting a research study, sometimes known as a clinical trial or clinical study, to understand brain development in children with Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) compared to typical children who do not have ADD, ADHD or other behavioral conditions.Who can participate?
Those eligible to participate are right-handed boys and girls, 8 to 12 years old, who:
- Have no ADD/ADHD, learning disabilities or any special education needs
AND - Have no other significant psychiatric, neurological or medical problems
Conditions
- Healthy Infants, Children and Adolescent Studies
What will happen in the study?
The study involves a full day visit to Cincinnati Children’s, plus an optional extra visit.
The following is a list of procedures that may take place during the study:
- An initial health screening
- Reading/math related questions
- Parent questionnaires about behavior
- MRI brain scan for research: a procedure which allows us to look at the brain’s structure and the level of important chemicals, including neurotransmitters
- Transcranial Magnetic Stimulation (TMS): a procedure which activates the brain so we can measure how it controls movements
- Computer games and tests of coordination
- Optional extra visit: participants will be given a small dose of a carbidopa/levodopa (sinemet®) pill or placebo (a pill that looks like the study drug but contains no medication), which is converted by the body to dopamine (dopamine is made naturally in the brain and is important for attention and motivation)
Parents interested in having their child participate will be emailed/mailed/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 good things that can happen from this research?
Your child may receive no direct benefit from participating in this study. The greatest benefit is that your child may be contributing to research that helps other children and may learn about science. Research studies are essential in finding new and improved treatments and diagnostic tools.What are the bad things that can happen from this research?
There are limited risks associated with the use of TMS. Based on previous studies involving both children and adults exposed to TMS, there may be mild and temporary side effects such as scalp discomfort, hand weakness and headaches. The study drug carbidopa/levodopa may cause nausea or stomach upset. However, a single dose of this medication is not anticipated to cause any serious side effects because it is used for many neurological conditions in children and adults and because the active component is what the brain uses naturally to make dopamine. Some individuals become anxious during MRI scans.
A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.
Will you/your child be paid to be in this research study?
Families will receive $20 per hour for up to 10 hours, depending on what parts of the study are completed, for their time and travel.Contact
Study CoordinatorTMSLab@cchmc.org
Cincinnati Children’s Hospital Medical Center
Division of Neurology
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Study Doctor
Donald Gilbert, MD, MSDirector, Tourette Syndrome and Movement Disorders Clinics
Cincinnati Children’s Hospital Medical Center
Division of Neurology
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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