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临床试验/NCT03706170
NCT03706170已完成不适用

Emotion Assessment to Study Consciousness in Awakening Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
electrodermal response

研究概览

简要总结

After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious.

The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness.

The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience.

In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • For Patients :
  • age between 18 and 80
  • acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month
  • level of consciousness assessed with the coma recovery scale revised (CRS-R)
  • patient with health insurance
  • informed consent signed by the patients or his representative
  • For Healthy participants:
  • age between 18 and 80
  • participant able to understand instructions and normal hearing
  • patient with health insurance
  • informed consent signed

排除标准

  • For Patients :
  • non controlled epilepsy
  • dysautonomic crisis
  • unstable medical state
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship
  • For Healthy participants:
  • neurological disorder
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty

结局指标

主要结局

electrodermal response

时间窗: at Day 1

skin conductance response measured with trans-cutaneus electrodes

次要结局

  • pupillary response(at Day 1)
  • heart rate modification(at day 1)
  • Variation of the intensity of different Event Related Potentials(at Day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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