Functional Imaging and Reading Deficit in Children With NF1

August 18, 2015 updated by: University Hospital, Toulouse

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France
        • Chu Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Children with reading disability
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

IQ (WISC-IV)

Reading tests (reading accuracy, reading speed, reading comprehension and strategy):

Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)

The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a "Flair" to allow UBO location.
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
Other: Children without reading disability
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.

IQ (WISC-IV)

Reading tests (reading accuracy, reading speed, reading comprehension and strategy):

Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)

The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a "Flair" to allow UBO location.
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood flow in milliliters per minute
Time Frame: day 1

Comparison of brain activations involved in phonological and visuo-spatial processing in 2 groups in children with NF1.

1 group with reading disability and 1 group without reading disability Search for a link between the presence of a large deletion of the gene and learning disorders.

day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yves Chaix, MD PhD, Chu Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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