跳至主要内容
临床试验/NCT02869698
NCT02869698已完成不适用

Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2009年6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
发起方
入组人数
192
试验地点
2
主要终点
Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.

研究概览

简要总结

This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

详细描述

Cognitive deficits after epilepsy surgery are poorly known particularly because the tools used to evaluate them. In addition, the prevention of certain postoperative deficits, is extremely difficult because of the lack of robust markers to anticipate. The various examinations conventionally used for this purpose (neuropsychological testing, functional MRI and cortical stimulation) does indeed provide insufficient information or difficult to interpret, so the development of improved methods appears as an imperative in the field of the epilepsy surgery.

SID appears as such particularly adapted to the case of epileptic patients explored SEEG to provide individualized cognitive map millimeter thereof without requiring, for additional invasive act, or risk of inducing unintended crisis. In practice, this clinical research project should lead to the definition of several simple cognitive tasks which, together, could be achieved by each volunteer patient in two or three hours, and then analyzed in a similar time to provide fast, even the patient is still explored SEEG and even before cortical electrical stimulation, a list of brain regions involved in most major cognitive functions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Drug-resistant partial epilepsy justifying a SEEG exploration
  • •Intellectual capacities compatible with the award of cognitive tasks

排除标准

  • •Pregnant or lactating women
  • •Patient deprived of liberty by a judicial or administrative
  • •Major patient subject to a measure of legal protection

研究组 & 干预措施

Evaluation of cognitive functions by Spectral Dynamic Imaging

Experimental

Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes

干预措施: Hybride electrode (Device)

Evaluation of cognitive functions by Spectral Dynamic Imaging

Experimental

Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes

干预措施: Macro electrode (Device)

Evaluation of cognitive functions by Spectral Dynamic Imaging

Experimental

Evaluation of cognitive functions by SDI will be conducted during the exploration SEEG (which usually lasts from 1 to 3 weeks), and started a few days after implantation of intracranial electrodes

干预措施: Spectral Dynamic Imaging (Procedure)

结局指标

主要结局

Functional brain mapping procedure using the EEG signal intracranial to minimize the risk of cognitive deficits associated with resection of the epileptogenic zone.

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

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

研究点 (2)

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