Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- electrocorticographic recordings
研究概览
简要总结
This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years-old
- •Subject with a non-recurrent glial lesion requiring surgery in vigilant condition;
- •Brain lesion located in the functional zone;
- •Major not protected within the meaning of the law;
- •Subject affiliated to a Health Insurance scheme;
- •No medical contraindication to performing an MRI (pacemaker);
- •No medical contraindication to surgery and anesthesia;
- •Karnofski index> 70;
- •Subject having signed an informed consent.
排除标准
- •Minor subject, pregnant or breastfeeding woman;
- •Major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
- •Subject hospitalized without consent;
- •Subject treated with antipsychotics (neuroleptic or lithium);
- •Subject who has already been treated for his glial lesion by surgery and / or radiotherapy;
- •Subject refusing to sign an informed consent.
- •Subject wishing to discontinue participation in the study before completion;
- •Subject for which the surgical intervention and / or the ECoG recording could not be carried out after admission to the operating room (whatever the reason).
研究组 & 干预措施
Subject with a non-recurrent glial lesion requiring surgery in vigilance
干预措施: ECoG : electrocorticography (Procedure)
结局指标
主要结局
electrocorticographic recordings
时间窗: 12 months
Intraoperative ECoG recordings (raw signals) acquired during awake surgery which in clinical practice couples cortical stimulation and simultaneous ECoG recordings with behavioral tests. The regions defined as electrophysiologically "connected" to the stimulated region will be those for which an afterdischarge is recorded (short-duration rhythmic activity following the stimulation) and/or a cortico-cortical evoked potential is obtained after a average of 5 successive stimulations.
次要结局
未报告次要终点