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Therapeutic Areas: Neurology
Disease Category: Neurologic Disorders
Location: United States, OH

Clinical Trial Details

Overview

Research Study Summary

Neurofibromatosis Type 1 (NF1) Study

Purpose

The purpose of this research study is to learn about brain development in typically developing children and children affected by the disease Neurofibromatosis Type 1 (NF1). We are especially interested in development of motor control, learning, and behavioral control and in how these skills related to connections in the brain. For example, in this study we will measure activity in brain cells involved in hand movement. We will also assess "neuroplasticity," which is how brain cells adapt and change in response to learning, experience, and disease. Persons affected by NF1 often have some problems with learning and may have Attention Deficit Hyperactivity Disorder (ADHD). In doing this research, we hope to better understand how to diagnose and treat people who have NF1.

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

Patient Inclusion Criteria: Children and teenagers with NF1 who may be eligible to participate are:

  • Either gender, any race, ethnicity or socioeconomic status.
  • Currently between 8 years 0 months and 18 years, 11 months, 30 days.
  • Willing to answer questions about NF1, ADHD, and related diagnoses.
  • Not pregnant, if female.
  • Able to participate in and sign an informed consent.

Patient Exclusion Criteria: Participants should not participate if they:

  • Have any medical objects or devices implanted in their bodies. For example, implanted electrical wires in the brain or neck (deep brain stimulator, vagal nerve stimulator), water draining tubes in the brain (VP shunt), blood vessel clips in the brain (aneurysm clips), heart electrical devices (cardiac pacemaker or defibrillator), or implanted tube for giving medications (medication port).
  • Currently use medications for depression, for bipolar disorder, for epilepsy, or for other serious neurological or psychiatric conditions. Note that use of some medications for ADHD treatment is allowed. If you are unsure whether one of these medications is being taken, the research team can discuss this.
  • Have daily seizures or have had a bad concussion where the brain was injured (traumatic brain injury).
  • Are pregnant or sexually active and not using birth control. Abstinence or verbal assurance of sexual activity with birth control will be permitted in some cases, after discussion of this issue with the research team, consistent with other IRB approved studies involving this population.

To Learn more
Gender

Both Male and Female

Age

8 to 18 Years

Overall Status

Recruiting

Duration

1 Days

Facility Type

N/A

Contact

Amanda Lewis, Study Coordinator
Cincinnati Children's Hospital Medical Center/Cincinnati Children's Research Foundation
Neurology, MLC 2015 3333 Burnet Avenue
Cincinnati, OH 45229-3039
Phone: 513-636-3781

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 166343

Date Last Changed: July 23, 2013


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