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Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments

Control group children without NF1 with the same reading level Neuropsychological assessments

Neuropsychological assessments:

Intelligence Quotient (WISC-IV)

Reading tests (reading accuracy, reading speed, reading comprehension and strategy):

Alouette test, Lobrot test, Odedys test. Visio-spatial skill (JLO, Thurston, Corsi tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)

Neuropsychological assessments

Yves CHAIX, Professor

A national, multicenter, randomized, transverse clinical trial, estimating the existence of phonological deficits in children with NF1 children compared with control children without NF1 with the same reading level.

To determine the phonological and visio -spatial performances at the NF1 children.

Reading Disability in Children With NF1

Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1

Evaluate whether there is a specificity of phonological deficits in children with NF1 compared with a population of children with the same age and same reading level, taking into account the intellectual level.

Studying the correlations between phonological deficits and visio-spatial and literacy skills.

University Hospital, Toulouse

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.

Tutoring Program I

Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.

Tutoring Program II

Laurie E. Cutting, Ph.D.

Martha Bridge Denckla, M.D.

Sheryl L. Rimrodt, M.D.

John Gore, Ph.D.

The goal of this trial is to determine if children with neurofibromatosis type 1 who have reading disabilities respond the same way-both behaviorally and neurobiologically-to specialized treatment programs as children with idiopathic reading disabilities do, and to determine which intervention is best for particular learner profiles.

The most common concern of parents of children with neurofibromatosis type 1 (NF-1) is learning disabilities (LD). Approximately one half of all children with NF-1 have LD-the most debilitating and common of which are reading disabilities.

The purpose of this study is to determine if children with NF-1 who have reading disabilities respond the same way-both behaviorally and neurobiologically-to specialized treatment programs known to improve the decoding deficits in children with idiopathic reading disabilities. The trial will also determine which intervention is best for particular learner profiles. The overall purpose of this research is to gain a deeper understanding of the characteristics and treatment of reading disabilities in NF-1.

In the trial, researchers will compare children with NF-1 who show weaknesses in reading to children with reading disabilities of no known cause (idiopathic) using two different interventions and behavioral and neurobiological measures. Both interventions focus on teaching sound-symbol relationships, but vary in terms of relative emphasis on verbal versus visual methods of teaching.

Scientists hope findings from the trial will advance knowledge about the best therapies for LD in children with NF-1. And, by further refining how children with NF-1 who have reading disabilities are similar (or different) to children with idiopathic reading disabilities, the researchers may be able to learn if reading interventions that address areas other than decoding will also benefit children with NF-1. Also, by understanding the similarities and/or differences in the neuropsychological and neurobiological profiles of children with NF-1 who have reading disabilities, and those without, scientists will be able to refine the cognitive phenotype and neurobiological characteristics of NF-1, which will further understanding of central nervous system abnormalities in NF-1.

Neurobiology and Treatment of Reading Disability in NF-1

Neurobiology and Treatment of Reading Disability in Neurofibromatosis Type 1 (NF-1)

De-identified behavioral data (Woodcock Johnson-III NU scores) may be shared with other researchers upon request. De-identified T1 structural neuroimaging scans will be shared with other researchers through a neuroimaging data warehouse or consortium.

This metric measures change in reading abilities, including word recognition and decoding, as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery - 3rd Edition Normative Update; WJ-III NU). The scores are reported as change in age-normed standard scores (a change of 15 standard score points would represent a change of 1 standard deviation in the general population).The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.

Neuroimaging data consists of functional MRI and structural MRI measures.

National Institute of Neurological Disorders and Stroke (NINDS)

Vanderbilt University

Associate Professor

Tutoring Program I

Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.

NF-Tutoring Program 1

Tutoring Program II

Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.

NF-Tutoring Program 2

Control group--children who do not have reading problems

Typically Developing Readers

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.

IRD-Tutoring Program 1

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.

IRD-Tutoring Program 2

These are children who have reading disabilities (without NF) but did not receive intervention until after the trial.

Waitlist Control

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program I

Tutoring Program I: Tutoring Program I is a structured multi-sensory program that is designed to gradually present the range of sounds and letters with focus on accuracy of phonological concepts and application of those concepts in phrases and sentences. The instruction uses a sequenced defined lesson plan with accuracy and automaticity criteria for skill progression. A range of manipulative and kinesthetic activities is outlined to maintain learner engagement in the intensive intervention design.

IRD- Tutoring Program 1

These are children with reading disabilities (without NF - ideopathic reading disabilities; IRD) who received Tutoring Program II

Tutoring Program II: Tutoring Program II is designed to teach visual and speech elements of reading separately at first, and then bring them together for maximum efficiency. The program uses the idea of teaching concepts about the structure of words. For example, students transfer the rules they have learned about one vowel or structure to another without specific instructions on the new one. Tutoring Program II incorporates pictures and activities to help remember strategies for increasing basic reading skills. Speed drills are also used for development of decoding automaticity.

Total

Age, Continuous

Sex: Female, Male

This metric measures reading abilities (word recognition and decoding) as assessed by standard educational assessments (Woodcock Johnson Psychoeducational Battery - 3rd Edition Normative Update; WJ-III NU). The scores are reported as age-normed standard scores, with higher scores reflecting better performance on the measure (mean=100, standard deviation=15, such that a score \>130 would be very superior and a score \<70 would be very low). The Basic Reading score is a normed composite of the WJ-III subtests Letter-Word Identification and Word Attack, representing word-level reading skill.

Woodcock Johnson Achievement Tests

Participants both with and without NF1 were determined by researcher-administered assessments as having Reading Difficulties or typically developing reading skills.

Small sample size; Different group sizes; Random assignment to treatment group (along with small sample size) produced some asymmetry of pretest score by treatment group, such that the NF-Tutoring Program 2 started with a higher group mean score.

Dr. Laurie Cutting

Change From Baseline in WJ-III Basic Reading Normative Update (Woodcock Johnson Psychoeducational Battery - 3rd Edition; WJ-III NU) Standard Score at 15 Hours

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reading Disability in Children With NF1	NCT02397967	Neurofibromatos...	Neuropsychologi...	8 Years - 12 Years	University Hospital, Toulouse
Neurobiology and Treatment of Reading Disability in NF-1	NCT00624234	Neurofibromatos... Reading Disabil...	Tutoring Progra... Tutoring Progra...	8 Years - 17 Years	Vanderbilt University
Reading Disability in Children With NF1	NCT02397967	Neurofibromatos...	Neuropsychologi...	8 Years - 12 Years	University Hospital, Toulouse

Spots Global Cancer Trial Database for reading disabilities