Reading Disability in Children With NF1

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Neurofibromatosis Type 1

Intervention / Treatment
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* Other: Neuropsychological assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age included between 8 and 12 years Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list : At least 6 café au lait spots 2 or more neurofibromas or 1 plexiform neurofibroma axillary or inguinal freckling 1 optic nerf glioma 2 or more Lisch nodules 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudoarthrosis 1 A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria Membership in a national insurance Consent of the child and the parents Exclusion Criteria: Mental retardation (QI T < 70) Treated or untreated epilepsy Visual deficit (visual Acuteness < 4/10 Presence of a symptomatic optic glioma Presence of a brain tumor.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children NF1<br>Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments | Other: Neuropsychological assessments<br>* 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)<br>|
| Placebo Comparator: Control group<br>Control group children without NF1 with the same reading level Neuropsychological assessments | Other: Neuropsychological assessments<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test. | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual-perceptual performance established from three tests: Test of Identical Forms (Thurstone), Judgment Test of orientation Lines (Benton) and global and partial deferral Tasks (S Valdois). | Studying the correlations between phonological deficits and visio-spatial and literacy skills. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NF1, children, reading disabilities