Pilot Study: Measure of the Potential Evoked With Electroencephalography and Electrocorticography by Electric Stimulation of the Brain During the Neurosurgery Awakened of the Infiltrative Glioma of Low Grade (OMS Type II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Measure of the potential evoked
研究概览
简要总结
This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.
The objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.
Having verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.
The collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.
详细描述
All the surgical operations will be realized by Professor Hugues DUFFAU. The DEMAR-INRIA team will assure the collection and the data processing electrophysiological, the management of the data and the methodological follow-up, as well as the writing of the report and the distribution of the results.
The quality assurance will be assured by a "minimal" monitoring by an assistant of clinical research for the department of the research and the innovation, to Montpellier, which will verify principally the consents.
The electrophysiological data digitized will be stored in the form of computer files via PowerLab.
All the analyses of treatment of signals required to highlight the potential evoked will be realized with the software Matlab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient carrier of a low-rank infiltrative glioma (OMS Type II) and presenting the indications to benefit from a surgical care in condition awakened for the first time.
- •Patient capable of understanding the nature, the purpose and the methodology of the research.
- •Having signed an informed consent writes before the inclusion in the research.
- •Membership or beneficiary of a national insurance scheme
排除标准
- •Systematic pathology with neurological appearance
- •Psychiatric disorders
- •History of psychotic disorders
- •History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology
- •Major protected by the law (supervision or guardianship)
- •Loss of liberty by court or administrative order
结局指标
主要结局
Measure of the potential evoked
时间窗: 2 months
Measured by electroencephalography and electrocorticography before the beginning of the surgery and before and after the surgical resection
次要结局
未报告次要终点