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临床试验/NCT02903784
NCT02903784已完成不适用

The Neural Basis of Language: A New Lighting. Study of Semantic Processing in MRI Mutimodale and Direct Electrical Stimulation

University Hospital, Montpellier0 个研究点目标入组 63 人开始时间: 2012年9月1日最近更新:
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
63
主要终点
functional score

研究概览

简要总结

According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults.

This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests, administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language.

详细描述

According to the O.M.S. Classification, grade 2 glioma is a pre-cancerous lesion, slowly progressive, infiltrating the central nervous system, mainly affecting young adults. Surgical excision of the tumor is the most appropriate care, with or without chemotherapy or radiotherapy.

This surgery should nevertheless be conducted in awake condition to achieve two conflicting goals: get maximum brain tissue infiltrated by the tumor while preserving the integrity of functional structures. So awake after opening the skull, the patient undergoes a series of preoperative tests (motor, sensory and / or language), administered by a speech therapist present in the operating room. This procedure allows the neurosurgeon to establish an individual functional brain mapping in real time, through the observation by the SLP of the patient's answers to direct electrical stimulation applied to the cortical and sub-cortical. This support is based on the extraordinary plasticity demonstrated by the brain in the presence of a slowly progressive lesion. To ensure the patient the highest achievable load should increase our understanding of brain function, including the neural bases of language, glioma grade 2 is predominantly localized functional area of language. Many studies apply to highlight the cortical organization of language, but the study of subcortical beams involved in this function, especially in the semantic language processing, has so far received less attention .

The use of electric direct intraoperative stimulation helps highlight the cortico-subcortical networks involved in language processing.

The new imaging techniques allow us to better understand the functional brain anatomy: the Diffusion Tensor can view the white matter bundles based on the diffusion of water molecules, functional MRI to visualize areas cortical functional.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients carry a grade glioma 2 functional area of language and presenting the information to receive surgical care provided in awake for the first time.
  • •or Healthy volunteers will be selected using a matching age and sex of patients in the study (matched to a patient on two of the first forty patients).

排除标准

  • •Subject presenting cons-indications to MRI (ventricular shunt valve, ferromagnetic foreign bodies, pacemaker, implantable defibrillators, cochlear hearing implant, claustrophobia, ....)
  • •History of head trauma, ischemic stroke or intracerebral hematoma.

研究组 & 干预措施

grade 2 glioma

Other

Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: fMRI (Device)

grade 2 glioma

Other

Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: tractography (Procedure)

grade 2 glioma

Other

Patient with grade 2 glioma use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: neuropsychological examination (Other)

healthy volunteers

Other

healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: fMRI (Device)

healthy volunteers

Other

healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: tractography (Procedure)

healthy volunteers

Other

healthy volunteers use a neuropsychological examination and brain imaging (fMRI and tractography)

干预措施: neuropsychological examination (Other)

结局指标

主要结局

functional score

时间窗: 1 day

The intraoperative testing is performed by an evaluator (speech / neuropsychologist), present in the operating room, the patient's side. Its role is to identify functional disturbances induced by direct electrical stimulation. To do this, two standardized tests are administered to the patient alternately for the duration of the awake period. These tests are presented on a computer screen in PowerPoint format, with a picture every four seconds.

次要结局

  • Evaluation orthophonic(3 month)
  • Imagery Data(6 month)
  • Imagery Data(5 day)
  • Imagery Data(1 day)
  • Evaluation orthophonic(1 day)
  • Evaluation orthophonic(5 day)

研究者

申办方类型
Other
责任方
Sponsor

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