ACTIVE_NOT_RECRUITING

Interventions for Reading Disabilities in NF1

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Conditions

Neurofibromatosis Type 1Learning DisabilityReading DisabilityNF1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neurobiology and Treatment of Reading Disability in NF1

Quick Facts

Study Start:2016-11
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02964884

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Individuals ages 8-20 (all participants)
  2. 2. Documented NF-1 (NF patients only)
  3. 3. If female, participant is post-menarche (NF patients only)
  4. 4. If male, participant has reached Tanner Stage 2 (NF patients only)
  5. 5. Participant able to swallow capsule (NF patients only, may be confirmed via swallowability test, described below)
  6. 6. Participant's English is sufficient for school (all participants)
  7. 7. Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions B-D listed below:
  8. 1. Child 7 years of age or less;
  9. 2. known uncorrectable visual impairment;
  10. 3. documented hearing impairment greater than or equal to a 25 dB loss;
  11. 4. medical contraindication to MRI procedures (e.g., metal devices);
  12. 5. any psychiatric, behavioral, or developmental disorder that would preclude active participation in in-depth tutoring sessions
  13. 6. Pregnant at time of screening.
  14. 7. Known conditions which are contraindicated to Lovastatin
  15. 1. Hypersensitivity to the medication
  16. 2. Uncontrolled Epilepsy
  17. 3. Metabolic Syndrome X, High Blood Sugar,
  18. 4. Muscle Damage Due to Autoimmunity
  19. 5. Stroke caused by Bleeding in the Brain, Loss of Memory,
  20. 6. Severely Low Blood Pressure
  21. 7. Liver Problems including Abnormal Liver Function Tests
  22. 8. Severe Renal Impairment,
  23. 9. Serious Muscle Damage that may Lead to Kidney Failure,
  24. 10. Recent Operation or significant Injury
  25. 11. Muscle Pain or Tenderness with Increase Creatinine Kinase,
  26. 12. Habit of Drinking Too Much Alcohol
  27. 13. Pregnant or lactating. - Lovastatin is contraindicated during pregnancy and in nursing mothers because it decreases synthesis of cholesterol and other products of the cholesterol biosynthesis pathway that are essential components for fetal development.
  28. 1. Children ages 8-17
  29. 2. Participant is a native English speaker
  30. 3. Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions 2-4 listed below:
  31. 1. Children 7 years of age or younger
  32. 2. previous diagnosis of Intellectual Disability;
  33. 3. known uncorrectable visual impairment;
  34. 4. documented hearing impairment greater than or equal to a 25 dB loss;
  35. 5. medical contraindication to MRI procedures (e.g., metal devices);
  36. 6. known IQ below 70;
  37. 7. a pervasive developmental disorder; and
  38. 8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, optic gliomas, and brain tumors (other than UBOs).
  39. 9. Comorbid severe psychiatric disorders will also be excluded.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Laurie Cutting, PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Sheryl L. Rimrodt-Frierson, MD
STUDY_DIRECTOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University
Nashville, Tennessee
United States

Collaborators and Investigators

Sponsor: Vanderbilt University

  • Laurie Cutting, PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
  • Sheryl L. Rimrodt-Frierson, MD, STUDY_DIRECTOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11
Study Completion Date2027-01

Study Record Updates

Study Start Date2016-11
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Neurofibromatosis Type 1
  • Learning Disability
  • Reading Disability
  • NF1

Additional Relevant MeSH Terms

  • Neurofibromatosis Type 1
  • Learning Disability
  • Reading Disability
  • NF1