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临床试验/NCT02422732
NCT02422732已完成不适用

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Percentage of children performing in full the protocol functional MRI

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Neuropsychological assessments (Other)

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

干预措施: morphological and functional MRI (fMRI) (Radiation)

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

干预措施: genetic analysis (Genetic)

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.

干预措施: Neuropsychological assessments (Other)

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.

干预措施: morphological and functional MRI (fMRI) (Radiation)

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.

干预措施: genetic analysis (Genetic)

结局指标

主要结局

Percentage of children performing in full the protocol functional MRI

时间窗: day 1

Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

次要结局

  • blood flow in milliliters per minute(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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