跳至主要内容
临床试验/NCT02577757
NCT02577757Unknown不适用

Establishing the Language Network With Independent Component Analysis of Resting State MRI

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers

研究概览

简要总结

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

详细描述

Patients with brain tumors including malignant gliomas located in eloquent areas have long been considered inoperable because of median survival and predictable postoperative sequelae. The improved prognosis with chemoradiotherapy and surgical resection as complete as possible questioned this attitude. The goal is to operate those patients without additional disabilities. The cortical electrostimulation intraoperative mapping in awake surgery can meet the eloquent areas. Identifying with fMRI these same areas to better specify in advance the way initially and shortened the time to awake exploratory surgery which improves patient comfort. However anxiety induced by the review in a pre-operative setting, a debutante aphasia often make problematic the realization of a formal language test. The analysis in the low frequency of spontaneous oscillations of large neuronal networks can help isolate network of language at rest without particular language test at the group analysis. This methodology, however, needs to be validated at the individual level before it can be applied to pathology.

Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persons major and minor.
  • Having given their written consent, or whose parents have given their written consent for minors.
  • Affiliated with the social security system
  • All patients eligible adults in awake surgery
  • Affiliated with the social security system
  • patient given their written consent

排除标准

  • Contraindications to MRI
  • Pregnant or breastfeeding women

结局指标

主要结局

MRI data obtained by comparing a formal language test to data obtained by a session of rest independent component analyzed in patients and volunteers

时间窗: 1 hour

次要结局

未报告次要终点

研究者

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

研究点 (2)

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