跳至主要内容
临床试验/NCT02628639
NCT02628639Unknown不适用

Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 28 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
28
主要终点
Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols

研究概览

简要总结

The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients in a vegetative state or a minimally conscious state
  • •agreement from families

排除标准

  • •patients with akinetic mutism or locked-in syndrome
  • •patients in a coma
  • •patients with damages in the inner or middle ear
  • •contraindication to a high-density electroencephalography exam

研究组 & 干预措施

electroencephalography recording

Experimental

Cerebral measurements from high-density electroencephalography after the presentation of personalized stimulations

干预措施: high-density electroencephalography (Device)

结局指标

主要结局

Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols

时间窗: standard stimulations: 28 days after recruiting patients

Depending of the personalized stimulation protocol, the differences of electrophysiological activity can the presence of event-related potentials (N100, mismatch negativity, P300, etc.) or alterations of neural oscillations. The personalized stimulation protocol will be chosen according to the families' feeling of a presence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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