Clinical trial NCT02397967: Reading Disability in Children With NF1
Official title: Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis Type 1
Keywords: NF1
children
reading disabilities
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 181
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Eligibility 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.

Primary outcomes:
measure: Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.
timeFrame: 24 hours
Secondary outcomes:
measure: 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).
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital femme-mére-enfant, Hospices civils de lyon
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nantes
country: France
facility: CHU Hôtel-Dieu, Clinic of Dermatology
city: Paris
country: France
facility: AP-HP Hopital Armand Trousseau
city: Toulouse
country: France
facility: Hôpital des Enfants
city: Tours
country: France
facility: Hopital Gatien de Clocheville
Study officials:
name: Yves CHAIX, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biotteau M, Tournay E, Baudou E, Destarac S, Iannuzzi S, Faure-Marie N, Castelnau P, Schweitzer E, Rodriguez D, Kemlin I, Dorison N, Rivier F, Carneiro M, Preclaire E, Barbarot S, Lauwers-Cances V, Chaix Y. Reading Comprehension Impairment in Children With Neurofibromatosis Type 1 (NF1): The Need of Multimodal Assessment of Attention. J Child Neurol. 2021 Jul;36(8):625-634. doi: 10.1177/0883073820981270. Epub 2021 Jan 28.