Functional Imaging and Reading Deficit in Children With NF1

Toulouse University Hospital

Status: Completed

Conditions: Neurofibromatosis Type 1

Treatments: Radiation: morphological and functional MRI (fMRI); Genetic: genetic analysis; Other: Neuropsychological assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT02422732

08 154 02

2008-A01493-52 (Registry Identifier)

Details and patient eligibility

About

A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

Full description

The principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with NF1 with or without reading disabilities.

Enrollment: 25 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No 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 pseudarthrosis
  • 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Children with reading disability

Other group

Description:

Children with NF1, with reading disability if their performances on reading assessment (Alouette Test) present a delay of at least 18 months, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis

Treatment:

Other: Neuropsychological assessments

Genetic: genetic analysis

Radiation: morphological and functional MRI (fMRI)

Children without reading disability

Other group

Description:

Children with NF1, without reading disability if their performances on reading assessment (Alouette Test) present a less than 18-month delay, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis.

Treatment:

Other: Neuropsychological assessments

Genetic: genetic analysis

Radiation: morphological and functional MRI (fMRI)