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Completed

NCT Number: NCT02422732

Functional Imaging and Reading Deficit in Children With NF1

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

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Key information

Conditions

Neurofibromatosis Type 1 Communication Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslexia Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Language Disorders Learning Disabilities Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurocutaneous Syndromes Neurodegenerative Diseases Neurodevelopmental Disorders Neurofibroma Neurofibromatoses Neurofibromatosis 1 Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Specific Learning Disorder

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuropsychological assessments

Other

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)

Radiation

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

Genetic

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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