Clinical Trials

Does Your Child Have ADD or ADHD? 8 to 12 Year Olds Needed for a Research Study

What is the purpose of this study?

The purpose of this research study is 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.  The focus is on learning more about the brain’s abilities to control coordinated hand and finger movements.

Who can participate?

Those eligible to participate are children 8 to 12 years old who:

  • Have been diagnosed with ADD or ADHD
  • Are right-handed

AND

  • Have no significant neurological, developmental or psychiatric diagnoses.

What is involved?

The study involves 2 visits.  The following is a list of procedures that may take place during the study:

  • An initial screening
  • Parent questionnaires
  • MRI brain scan
  • Clinical assessment/neuropsychological testing (achievement testing)
  • Several tests of coordination
  • A procedure called a Transcranial Magnetic Stimulation (TMS) which looks at brain development and motor skills
  • Computer games
  • A dose of a carbidopa/levodopa (sinemet®) pill or placebo (a pill that looks like the study drug but contains no medication)

A detailed list of procedures will be provided to anyone interested in knowing more about this study.  

What are the benefits?

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.  Research studies are essential in finding new and improved treatments and diagnostic tools.

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?

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, furthermore, a single dose of this medication is not anticipated to cause any serious side effects.

A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.

Do participants receive pay, compensation or reimbursement?

Families will receive up to $50 per day (for 2 days) for their participation.

Who should I contact for more information?

Cameron Laue

cameron.laue@cchmc.org

513-803-7296

Principal Investigator

Donald Gilbert, MD, MS

Director, Tourette Syndrome and Movement Disorders Clinics

Cincinnati Children’s Hospital Medical Center

Division of Neurology