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临床试验/NCT04174820
NCT04174820Unknown不适用

Child's Study of the Distant Impact of Posterior Fossa Injury on Motor Skills, Language, Cognitive Functioning, and Social Cognition - a Combination of Clinical Assessments and Brain Imaging

University Hospital, Angers5 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2020年11月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
145
试验地点
5
主要终点
Structural and functional connectives in brain MRI

研究概览

简要总结

One of the major complications of posterior fossa surgery is Posterior Fossa Syndrome (PFS). This syndrome is due to a possible complication of surgical excision of a tumor of the cerebellum (4th ventricle) and is characterized by transient postoperative mutism, dysarthria, behavioral, and affective disorders, as well as motor disorders. PFS is thought to be related to axonal lesions. The long-term consequences on the cognitive and psychosocial sphere of PFS have been widely documented. On the other hand, the literature concerning the consequences of this syndrome on language is much restricted. Beyond the language, the role of cerebellum would be central in cognition, some authors even comparing it to a great "conductor" who would underlie the learning of most motor and cognitive automatisms.

详细描述

The physiopathology and the anatomo-functional correlates of motor, cognitive, and language functions after surgery of PF tumors are still rare and little known. The objective of this study is to analyze them via morphometric MRI analysis and functional and structural connectivity in children away from PF surgery, coupled with clinical data analysis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patient with a low grade glioma of the posterior fossa or a medulloblastoma
  • Healthy volunteers without any tumor in the posterior fossa (control case)
  • At one year of the last treatment for the retrospective groups, or patient who have an indication to a surgery of a tumor of the posterior fossa
  • Eligibility to a functional MRI
  • Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
  • Affiliated to a Social Security scheme

排除标准

  • Antecedent of neurologic, metabolic or genetic disease
  • Brainstem glioma
  • Have a contraindication to a MRI

结局指标

主要结局

Structural and functional connectives in brain MRI

时间窗: One day

Review and compare, in MRI, the structural and functional cerebellar-hemispheric connectives. The primary endpoint the analysis of fMRI brain mapping in accordance to the relations with the motor functions (balance and dexterity), cognitive, behavioral/social cognition and language after treatment for a child's posterior fossa tumor (with or without posterior fossa syndrome) and, in comparison with matched control group on age, sex and level study. The MRI data will be the subject of a specific statistical treatment, via dedicated software, which will be implemented under the control of the investigators who have conducted such an fMRI analysis in previous studies. Various brain mapping can be established from the data collected. It may include statistical comparisons between different preselected regions, and different experimental conditions, or correlation studies between brain activation and clinical parameters.

次要结局

  • Social cognition functions and the cognitive function: recognition of the affects(One day)
  • Social cognition functions and the cognitive function: flexibility(One day)
  • Dexterity with Box and Blocks test(One day)
  • The balance and the walk(One day)
  • Language functions(One day)
  • Social cognition functions and the cognitive function: behavioural executive functions(One day)
  • Dexterity with Nine Hole Peg test(One day)
  • Social cognition functions and the cognitive function: perceptual and verbal reasoning(One day)
  • Patients characteristics(One day)
  • Quality of life of patients: PedsQL questionnaire(One day)

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (5)

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