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Reading Disability in Children With NF1

Primary Purpose

Neurofibromatosis Type 1

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological assessments
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neurofibromatosis Type 1 focused on measuring NF1, children, reading disabilities

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hopital femme-mére-enfant, Hospices civils de lyon
  • Hôpital Gui de Chauliac
  • CHU Hôtel-Dieu, Clinic of Dermatology
  • AP-HP Hopital Armand Trousseau
  • Hôpital des Enfants
  • Hopital Gatien de Clocheville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Children NF1

Control group

Arm Description

Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 13, 2015
Last Updated
March 25, 2015
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02397967
Brief Title
Reading Disability in Children With NF1
Official Title
Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis Type 1
Keywords
NF1, children, reading disabilities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children NF1
Arm Type
Experimental
Arm Description
Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group children without NF1 with the same reading level Neuropsychological assessments
Intervention Type
Other
Intervention Name(s)
Neuropsychological assessments
Intervention Description
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)
Primary Outcome Measure Information:
Title
Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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).
Description
Studying the correlations between phonological deficits and visio-spatial and literacy skills.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves CHAIX, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital femme-mére-enfant, Hospices civils de lyon
City
Lyon
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Gui de Chauliac
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hôtel-Dieu, Clinic of Dermatology
City
Nantes
ZIP/Postal Code
44903
Country
France
Facility Name
AP-HP Hopital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital des Enfants
City
Toulouse
ZIP/Postal Code
31073
Country
France
Facility Name
Hopital Gatien de Clocheville
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33507832
Citation
Biotteau M, Tournay E, Baudou E, Destarac S, Iannuzzi S, Faure-Marie N, Castelnau P, Schweitzer E, Rodriguez D, Kemlin I, Dorison N, Rivier F, Carneiro M, Preclaire E, Barbarot S, Lauwers-Cances V, Chaix Y. Reading Comprehension Impairment in Children With Neurofibromatosis Type 1 (NF1): The Need of Multimodal Assessment of Attention. J Child Neurol. 2021 Jul;36(8):625-634. doi: 10.1177/0883073820981270. Epub 2021 Jan 28.
Results Reference
derived

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Reading Disability in Children With NF1

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