Functional Imaging and Reading Deficit in Children With NF1

NCT02422732 | Completed

• 2 other identifiers: 08 154 022008-A01493-52
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurofibromatosis Type 1

Keywords

NF1; Children; Reading disability; Morphological and functional MRI; Genetic analysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• blood flow in milliliters per minute

  day 1

Study Arms (2)

Children with reading disability

OTHER

Children with NF1, with reading disability if their performances on reading assessment (Alouette Test) present a delay of at least 18 months, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis

Other: Neuropsychological assessments; Radiation: morphological and functional MRI (fMRI); Genetic: genetic analysis

Children without reading disability

OTHER

Children with NF1, without reading disability if their performances on reading assessment (Alouette Test) present a less than 18-month delay, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis.

Other: Neuropsychological assessments; Radiation: morphological and functional MRI (fMRI); Genetic: genetic analysis

Interventions

Neuropsychological assessments OTHER

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)

Children with reading disability; Children without reading disability

morphological and functional MRI (fMRI) RADIATION

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.

Children with reading disability; Children without reading disability

genetic analysis GENETIC

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

Children with reading disability; Children without reading disability

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• or more neurofibromas or 1 plexiform neurofibroma
• axillary or inguinal freckling
• optic nerf glioma
• or more Lisch nodules
• osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudarthrosis
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Dyslexia

Interventions

Genetic Testing

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; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Yves Chaix, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 21, 2015
• Study Start: March 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

FR (1)