Interventions for Reading Disabilities in NF1 (NCT02964884) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
Interventions for Reading Disabilities in NF1
United States120 participantsStarted 2016-11
Plain-language summary
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.
Who can participate
Age range8 Years ā 20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Individuals ages 8-20 (all participants)
ā. Documented NF-1 (NF patients only)
ā. If female, participant is post-menarche (NF patients only)
ā. If male, participant has reached Tanner Stage 2 (NF patients only)
ā. Participant able to swallow capsule (NF patients only, may be confirmed via swallowability test, described below)
ā. Participant's English is sufficient for school (all participants)
ā. Participant must either answer "yes" to question A, or answer "yes" to at least 2 items for questions B-D listed below:
ā. Child 7 years of age or less;
Exclusion criteria
ā. Children ages 8-17
ā. Participant is a native English speaker
What they're measuring
1
Woodcock Johnson Tests of Achievement IV
Timeframe: 24 weeks
2
Woodcock Reading Mastery Test-III
Timeframe: 24 weeks
3
Test of Word Reading Efficiency-2
Timeframe: 24 weeks
4
Experimental Word and Pseudoword Lists
Timeframe: 24 weeks
5
Test of Silent Contextual Reading Fluency-2
Timeframe: 24 weeks
6
Comprehensive Test of Phonological Processing-2
Timeframe: 24 weeks
7
Delis Kaplan Executive Function System
Timeframe: 24 weeks
8
Visuospatial Learning and Memory, Morris Water Maze
Timeframe: 24 weeks
9
Visuospatial Learning and Memory, Judgment of Line Orientation