Reading Disability in Children With NF1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-04-30

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.

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Detailed Description

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

Conditions

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Neurofibromatosis Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Children NF1

Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments

Group Type EXPERIMENTAL

Neuropsychological assessments

Intervention Type OTHER

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)

Control group

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

Group Type PLACEBO_COMPARATOR

Neuropsychological assessments

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes