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Completed

NCT Number: NCT02397967

Reading Disability in Children With NF1

A national, multicenter, randomized, transverse clinical trial, estimating the existence of phonological deficits in children with NF1 children compared with control children without NF1 with the same reading level.

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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

Hopital femme-mére-enfant, Hospices civils de lyon, Lyon, France

Loading trial locations.

About this study

To determine the phonological and visio -spatial performances at the NF1 children.

Who can participate

Healthy volunteers accepted: Yes

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 pseudoarthrosis
  • 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

Neuropsychological assessments:

Intelligence Quotient (WISC-IV)

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

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

Primary outcomes

  1. Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.

    Time frame: 24 hours

    Evaluate whether there is a specificity of phonological deficits in children with NF1 compared with a population of children with the same age and same reading level, taking into account the intellectual level.

Secondary outcomes

  1. Visual-perceptual performance established from three tests: Test of Identical Forms (Thurstone), Judgment Test of orientation Lines (Benton) and global and partial deferral Tasks (S Valdois).

    Time frame: 24 hours

    Studying the correlations between phonological deficits and visio-spatial and literacy skills.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 25, 2015
Registry last updated
Mar 26, 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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