Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children

NCT03518710 | Unknown

• 2 other identifiers: RC31/17/03762017-A02907-46
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. The main objective of this study is to clarify the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. In particular, this project allow the investigators to study more precisely the relations between perceptual, oculomotor and visuo-attentional skills in NF1 children and reading abilities. In addition, a new oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators believe that the early intervention for perceptual, visuo-attentional or oculomotor problems may promote academic skill development.

Conditions

Neurofibromatosis Type 1

Keywords

child; reading; vision; attention; therapeutical perspectives

Outcome Measures

Primary Outcomes (3)

• Evaluation of the score obtained for Oculomotor Processes

  The visual process : Oculomotor Processes : Vertical,Horizontal Time with the Ratio with the Developmental Eye Movement Test (DEM test) : a standard of evaluation oculomotor in children with reading difficulties

  1 day

• Evaluation of the composite score obtained for Visuo-perceptual process

  The visual process : Visuo-perceptual process : it's a composite score : Composite score of perceptual treatment with pure visual perception score and visuo-motor integration with a Developmental Test of Visual Perception, 3rd (DTVP3) test is Visual perception development test

  1 day

• Evaluation of the score obtained : Visual-attentional process

  Visual-attentional process : reaction time (milli Sec) with the percentage of correct answers to the computerized Stroop to show that attention is a selective process and that it is very difficult to read and name colors at the same time

  1 day

Secondary Outcomes (1)

• Alouette Reading Test

  1 day

Study Arms (1)

Children with NF1

EXPERIMENTAL

One experimental group of NF1 children with 3 reading levels (1st grade, 2nd grade and 3rd grade). For this research they will pass : * Neuropsychological evaluation * Evaluation of the reading assistance technique

Other: Neuropsychological evaluation; Other: Evaluation of the reading assistance technique

Interventions

Neuropsychological evaluation OTHER

Neuropsychological evaluation (about 60 min) the same day realized by a student in Science Thesis under the responsibility of Prof. Yves Chaix and including: * Process evaluation: * Oculomotors: DEM test (5min) * Visuo-attention: computerized STROOP (15min) * Visuo-Perceptive: DTVP3 (30min) * Phonological \& lexical: Exalang (10min)

Children with NF1

Evaluation of the reading assistance technique OTHER

Evaluation of the reading assistance technique (about 30 min) and comprising: \- Reading evaluation:Test lark (3min) Experimental task: 3-way help with reading (without help, color help and highlight help (25 min)

Children with NF1

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child with a NF1 following the clinically-based criteria agreed at the international Consensus Conference
• Age between 7 and 9 years old child in 1st - 3rd grades with 5 children/grade
• Informed children and written consent obtained from one of the parents or other lawful representative
• Child who is covered by the social security scheme

You may not qualify if:

• left-handed children
• associated neurological disorder such as brain tumors or epilepsy
• mental retardation (IQ \<70 or Wechsler Intelligence Scale for Children (WISC) scores SIM et IC \< 7)
• children with Autism Spectrum Disorder
• diagnosis of attention deficit hyperactivity disorder (ADHD) (DSM-IV), with presence of hyperactive-impulsive or inattentive symptom
• pharmaceutical treatment (e.g., anti-depressants, anxiolytics)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neurofibromatosis 1

Condition Hierarchy (Ancestors)

Neurofibromatoses; 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; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yves Chaix, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Chaix, MD

CONTACT

05 34 55 85 76; chaix.y@chu-toulouse.fr

Isabelle Olivier, PhD

CONTACT

05 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 8, 2018
• Study Start: August 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)