Functional Imaging and Reading Deficit in Children With NF1
NCT ID: NCT02422732
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2009-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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
Neuropsychological assessments
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)
morphological and functional MRI (fMRI)
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.
genetic analysis
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
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.
Neuropsychological assessments
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)
morphological and functional MRI (fMRI)
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.
genetic analysis
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
Interventions
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Neuropsychological assessments
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)
morphological and functional MRI (fMRI)
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.
genetic analysis
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
Eligibility Criteria
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Inclusion Criteria
* 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
* Treated or untreated epilepsy
* Visual deficit (visual Acuteness \< 4/10
* Presence of a symptomatic optic glioma
* Presence of a brain tumor.
8 Years
12 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Yves Chaix, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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CHU Toulouse
Toulouse, , France
Countries
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Other Identifiers
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2008-A01493-52
Identifier Type: REGISTRY
Identifier Source: secondary_id
08 154 02
Identifier Type: -
Identifier Source: org_study_id
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