Children's and Adolescent Medicine

Neurofibromatosis Type 1 (NF1) Study

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting is a research study, sometimes referred to as a clinical trial or clinical study, which measures brain activity in children with neurofibromatosis type 1 (NF1), to evaluate differences in learning and behavior in children and teenagers with NF1 compared to typically developing children, to eventually improve options for treatment.

Who will be included in this study?

Children and teenagers 8 to 18 years old with NF1 may be eligible to participate.

What is involved?

The study includes one visit which lasts approximately 3 to 4 hours. The following is a list of procedures that will take place during the study:

A study coordinator or study doctor will:

Ask you (as the participant) or the you (as the parent) and your child questions which will which help to estimate IQ and reading ability, identify ADHD symptoms, etc.
Perform some tests to assess your (if the participant) or your child’s motor skills, coordination and balance
Take measurements of your (if the participant) or your child’s hand and brain function using transcranial magnetic stimulation (TMS), a hand-held magnetic coil which helps to measure how brain cells communicate with each other

You (if the participant) or your child will have a brief physical exam
You will be called the next day at home to see if you have any concerns and/or to see if you (if the participant) or your child has had any side effects

What are the benefits?

There is no direct medical benefit for you or your child from participating in this research study, but it is possible that what we learn from this research study might help people with NF1 in the future, as we will have new knowledge about neurofibromatosis.

Will I get all the facts about the study?

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 you as the participant or as the parent or guardian have 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 transcranial magnetic stimulation (TMS). The potential risks and discomforts are mild and temporary and include scalp discomfort, hand weakness or pain, headache, neck or arm pain or tingling. A detailed list of risks and discomforts will be provided to those interested in knowing more about this study.