Emotion Assessment to Study Consciousness in Awakening Patients
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
- 是
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)
