Reading Disability in Children With NF1

Not Applicable

Completed

• Conditions: Neurofibromatosis Type 1
• Interventions: Other: Neuropsychological assessments

• Registration Number: NCT02397967
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children NF1	Neuropsychological assessments	Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments
Control group	Neuropsychological assessments	Control group children without NF1 with the same reading level Neuropsychological assessments

Primary Outcome Measures

Name	Time	Method
Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.	24 hours	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

Name	Time	Method
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).	24 hours	Studying the correlations between phonological deficits and visio-spatial and literacy skills.

Trial Locations

Locations (6)

Hopital Gatien de Clocheville; 🇫🇷 Tours, France

Hopital femme-mére-enfant, Hospices civils de lyon; 🇫🇷 Lyon, France

AP-HP Hopital Armand Trousseau; 🇫🇷 Paris, France

CHU Hôtel-Dieu, Clinic of Dermatology; 🇫🇷 Nantes, France

Hôpital des Enfants; 🇫🇷 Toulouse, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France