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Clinical Trials/NCT02422732
NCT02422732CompletedNot Applicable

Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children

University Hospital, Toulouse1 site in 1 country25 target enrollmentStarted: March 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Percentage of children performing in full the protocol functional MRI

Study Overview

Brief Summary

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

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
8 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Children with reading disability

Other

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

Intervention: Neuropsychological assessments (Other)

Children with reading disability

Other

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

Intervention: morphological and functional MRI (fMRI) (Radiation)

Children with reading disability

Other

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

Intervention: genetic analysis (Genetic)

Children without reading disability

Other

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.

Intervention: Neuropsychological assessments (Other)

Children without reading disability

Other

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.

Intervention: morphological and functional MRI (fMRI) (Radiation)

Children without reading disability

Other

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.

Intervention: genetic analysis (Genetic)

Outcomes

Primary Outcomes

Percentage of children performing in full the protocol functional MRI

Time Frame: day 1

Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

Secondary Outcomes

  • blood flow in milliliters per minute(day 1)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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