Functional Imaging and Reading Deficit in Children With NF1

Neurofibromatosis Type 1 Clinical Trial

Official title:

Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422732
• Other study ID #: 08 154 02
• Secondary ID: 2008-A01493-52
• Status: Completed
• Phase: N/A
• First received: March 27, 2015
• Last updated: August 18, 2015
• Start date: March 2009
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

Description:

The principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with NF1 with or without reading disabilities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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 pseudarthrosis

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Neurofibromatosis Type 1

Intervention

Other:
• Neuropsychological assessments
IQ (WISC-IV) Reading tests (reading accuracy, reading speed, reading comprehension and strategy): Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)

Radiation:
• morphological and functional MRI (fMRI)
The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a "Flair" to allow UBO location.

Genetic:
• genetic analysis
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children performing in full the protocol functional MRI	Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.	day 1	No
Secondary	blood flow in milliliters per minute	Comparison of brain activations involved in phonological and visuo-spatial processing in 2 groups in children with NF1.; 1 group with reading disability and 1 group without reading disability Search for a link between the presence of a large deletion of the gene and learning disorders.	day 1	No