Reading Disability in Children With NF1

Toulouse University Hospital

Status: Completed

Conditions: Neurofibromatosis Type 1

Treatments: Other: Neuropsychological assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT02397967

08 113 01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 181 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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181 participants in 2 patient groups, including a placebo group

Children NF1

Experimental group

Description:

Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments

Treatment:

Other: Neuropsychological assessments

Control group

Placebo Comparator group

Description:

Control group children without NF1 with the same reading level Neuropsychological assessments

Treatment:

Other: Neuropsychological assessments