跳至主要内容
临床试验/NCT02875964
NCT02875964已完成不适用

Definition of Links Between Non-invasives Methods and Intracerebral EEG With Simultaneous Recordings.

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年10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
60
试验地点
2
主要终点
The number of epileptic discharges

研究概览

简要总结

Presurgical evaluation of epileptic patients require a precise mapping of cerebral regions implied in epileptic discharges and in normal function.

The current practice in most cases is to implant intracerebral electrodes in order to localize these regions in a reliable manner. However, non-invasive methods have been developed in order to record brain activity with no risk for the patient.

Still, it is necessary to validate and improve the signal processing methods and the underlying models these methods in order to optimize their use in clinical practice. To do so, it is necessary to record simultaneously electroencephalogram (EEG) and magnetoencephalogram (MEG) and stereo encephalogram SEEG (intracerebral). Such simultaneous recordings will permit to confront the exact same activity recorded non-invasively at the surface of the head, and represented on the brain thanks to the model and directly within the brain.

The objective is to define the conditions under which one can represent faithfully the activity measured intracerebrally from the surface measurements.

It will be record simultaneously MEG, scalp EEG and intracerebral EEG on a series of 60 patients. It will be record resting state signals, as well as stimulation protocols. The interictal epileptic discharges will be marked on the different modalities, and evoked potentials/fields computed in response to protocols. Sensitivity of recordings to activity visible on depth recordings will be evaluated as a function of localization of brain generators. Advanced signal processing methods will be used such as source localization and independent component analysis, in order to increase sensitivity of measures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • - Patients for whom implanting intracerebral electrodes is underway

排除标准

  • Patients minors
  • Pregnant or lactating women

研究组 & 干预措施

registration of intracerebral activity

Experimental

epileptic patient receiving implantation of intracranial electrodes

干预措施: electroencephalogram (Device)

registration of intracerebral activity

Experimental

epileptic patient receiving implantation of intracranial electrodes

干预措施: magnetoencephalogram (Device)

结局指标

主要结局

The number of epileptic discharges

时间窗: 60 months

Measurement of epileptic activity by electroencephalogram

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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