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Functional Imaging and Reading Deficit in Children With NF1

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ClinicalTrials.gov Identifier: NCT02422732
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis Type 1 Other: Neuropsychological assessments Radiation: morphological and functional MRI (fMRI) Genetic: genetic analysis Not Applicable

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  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children
Study Start Date : March 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
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
Other: 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)


Radiation: 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: 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.
Other: 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)


Radiation: 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: genetic analysis
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.




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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422732


Locations
France
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Yves Chaix, MD PhD CHU Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02422732     History of Changes
Other Study ID Numbers: 08 154 02
2008-A01493-52 ( Registry Identifier: ID-RCB )
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Toulouse:
NF1
Children
Reading disability
Morphological and functional MRI
Genetic analysis

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms