Reading Disability in Children With NF1

Neurofibromatosis Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397967
• Other study ID #: 08 113 01
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: March 25, 2015
• Start date: June 2009
• Est. completion date: April 2014

Study information

• Verified date: March 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Dyslexia
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Hopital femme-mére-enfant, Hospices civils de lyon	Lyon
France	Hôpital Gui de Chauliac	Montpellier
France	CHU Hôtel-Dieu, Clinic of Dermatology	Nantes
France	AP-HP Hopital Armand Trousseau	Paris
France	Hôpital des Enfants	Toulouse
France	Hopital Gatien de Clocheville	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No