Medication + Reading Tutoring for Learning Disabilities in Neurofibromatosis Type 1
Trial Summary
What is the purpose of this trial?
Neurofibromatosis Type 1 (NF1) is a common genetic disorder that is associated with a four times greater risk of learning disabilities, including reading disabilities, and a deficiency of neurofibromin - a protein important in a signaling pathway that regulates learning and memory. Our previous work (NS49096) demonstrated that school-age children with NF+RD can respond to standard phonologically-based reading tutoring originally developed to treat reading disability in the general population. Combining our work with that by other researchers suggesting that a medication (Lovastatin) may counteract the effects of the deficient neurofibromin, and possibly ameliorate learning disabilities in NF1, the investigator propose to examine the synergistic effects of medication plus reading tutoring.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not be on psychotropic medications, except for stimulant medication for ADHD. If you are taking other medications, it's best to discuss this with the trial coordinators.
What data supports the effectiveness of the treatment for learning disabilities in children with neurofibromatosis type 1?
Research shows that phonics training, a type of reading tutoring, can improve reading skills in children with neurofibromatosis type 1 who have reading difficulties. Additionally, attention, which affects reading comprehension, is a key area to address in these children, suggesting that targeted reading interventions could be beneficial.12345
How is the Reading Tutoring Intervention treatment different from other treatments for learning disabilities in Neurofibromatosis Type 1?
The Reading Tutoring Intervention is unique because it focuses on phonics training, which helps children with Neurofibromatosis Type 1 improve their reading skills by teaching them how to connect sounds with letters. This approach is particularly beneficial for children with NF1 who often struggle with phonological dyslexia, a condition where they have difficulty using spelling-to-sound rules to read.12567
Research Team
Laurie Cutting, PhD
Principal Investigator
Vanderbilt University Medical Center
Sheryl L. Rimrodt-Frierson, MD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for English-speaking individuals aged 8-20 with Neurofibromatosis Type 1 (NF1) and reading disabilities. They must be able to swallow capsules, have documented NF-1, and females should be post-menarche. Exclusions include living outside the US, pregnancy, liver or severe kidney issues, recent surgery or injury, excessive alcohol use, certain medications or conditions contraindicating Lovastatin.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lovastatin or placebo and one week of intensive, one-on-one reading tutoring intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of reading tutoring long-term
Treatment Details
Interventions
- Lovastatin
- Reading Tutoring Intervention
Reading Tutoring Intervention is already approved in United States for the following indications:
- Reading Disabilities in Neurofibromatosis Type 1 (NF1)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator