Looking for Participants for Study About Reading in NF1

The Education and Brain Sciences Research lab at Vanderbilt University is seeking participants for a new research study! The purpose of the study is to understand more about children and young adults with Neurofibromatosis Type 1 (NF-1) who also have difficulty with reading. People with NF-1 sometimes have trouble learning to read, and we would like to know more about the best ways to treat these reading difficulties. This study is to evaluate the effectiveness of a medication called Lovastatin and reading interventions in treating reading difficulties in children with NF1.

Purpose

The purpose of the study is to understand more about children and young adults with Neurofibromatosis Type 1 (NF1) who also have difficulty with reading. People with NF1 sometimes have trouble learning to read, and we would like to know more about the best ways to treat these reading difficulties. This study is to evaluate the effectiveness of a medication called Lovastatin and reading interventions in treating reading difficulties in children and young adults with NF1. There will be four different groups. Two groups will only have people with NF (called “NF Groups”), and two groups will only have people without NF (called “RD Groups”).

1: NF Group: Reading tutoring program and a medication called Lovastatin

2: NF Group: Reading tutoring program and no Lovastatin (placebo)

3: RD Group: Reading tutoring program and no medication

4: RD Group: No reading (sham) tutoring and no medication

Your child will be assigned randomly (like a flip of a coin) to one of the NF groups. You are being asked to allow your child to join the study because your child has Neurofibromatosis Type 1. Lovastatin is not approved by the Food and Drug Administration for the treatment of reading trouble due to Neurofibromatosis Type 1.

We will enroll a total of 120 people with and without NF1 between the ages of 8-20 years’ old

Who can participate?

Individuals ages 8 to 20 with Neurofibromatosis Type 1

What does participation involve?

Children will participate in four Magnetic Resonance Imaging Scan (MRI) and behavioral testing sessions as outlined below; specific tests and MRI procedures. Note that to minimize fatigue, testing for Visits 1 and 3 will be over two days, approximately 3-4 hours each day. Children will receive 20 mg Lovastatin for 2 weeks and then 40 mg Lovastatin for the remaining 11 weeks.

Benefits

The benefits to science and humankind that might result from this study. We may learn something that will help other children with reading difficulty, with and without NF1, someday.

Your child may directly benefit from either study medication, tutoring program, or both if assigned to that condition. We do not know for certain if being in this study will help your child.

Compensation

• Travel reimbursement available for NF-1 families living outside middle TN area for airfare and hotel
• Check for $150 for the first visit, $750 for the second visit, and $150 for the last visit
• Report of child’s performance on assessment measures (if first visit is completed)

Where?

Vanderbilt University located in Nashville, TN

When?

Study visits take place Monday through Friday. Funding provided, we will be enrolling participants over the next 3-4 years.

Contact information

Education and Brain Sciences Research Lab
(615)875-5534

Study Flyer