ClinicalTrials.gov
ClinicalTrials.gov Menu

Reading Disability in Children With NF1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02397967
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neurofibromatosis Type 1 Other: Neuropsychological assessments Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1
Study Start Date : June 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: Children NF1
Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments
Other: Neuropsychological assessments

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)


Placebo Comparator: Control group
Control group children without NF1 with the same reading level Neuropsychological assessments
Other: Neuropsychological assessments

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 Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

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): NCT02397967


Locations
France
Hopital femme-mére-enfant, Hospices civils de lyon
Lyon, France, 69677
Hôpital Gui de Chauliac
Montpellier, France, 34295
CHU Hôtel-Dieu, Clinic of Dermatology
Nantes, France, 44903
AP-HP Hopital Armand Trousseau
Paris, France, 75012
Hôpital des Enfants
Toulouse, France, 31073
Hopital Gatien de Clocheville
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Yves CHAIX, Professor

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02397967     History of Changes
Other Study ID Numbers: 08 113 01
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Toulouse:
NF1
children
reading disabilities

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Dyslexia
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
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders