EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients (EXPRESONREA)
EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.
Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.
Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.
研究概览
详细说明
Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC.
In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing.
Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Estelle Pruvost-Robieux, MD
- 电话号码：+ 33 1 45 65 81 89
- 邮箱：e.pruvost@ghu-paris.fr
研究联系人备份
- 姓名：Martine Gavaret, Professor
- 电话号码：+ 33 1 45 65 81 89
- 邮箱：m.gavaret@ghu-paris.fr
学习地点
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Paris、法国、75014
- 招聘中
- GHU Paris Psychiatrie Neurosciences
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接触：
- Estelle Pruvost-Robieux, MD
- 电话号码：+33 1 45 65 81 89
- 邮箱：e.pruvost@ghu-paris.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age over 18
- Disorder of consciousness defined as :
Glasgow coma scale < 8 or >8 but
- eyes opening to pain only
- No response to basic command
- Available neuro-imagery (CT-scan or MRI)
- Normal temperature (no fever or hypothermia)
- Normal blood pressure during neurophysiologic evaluation
- Given consent from relatives
Exclusion Criteria:
- Brain death
- Known deafness
- Severe sepsis uncontrolled during neurophysiologic evaluation
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Whole group
The whole group listen successively the 3 paradigms :
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Evoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months
大体时间：3 months from DOC evaluation
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Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
大体时间：3 months from DOC evaluation
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Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
大体时间：3 months from DOC evaluation
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Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
大体时间：3 months from DOC evaluation
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Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
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3 months from DOC evaluation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
大体时间：7, 14 and 28 days from DOC evaluation
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Determination of the negative predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
大体时间：7, 14 and 28 days from DOC evaluation
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Determination of the positive predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
大体时间：7, 14 and 28 days from DOC evaluation
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Determination of the sensibility of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
大体时间：7, 14 and 28 days from DOC evaluation
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Determination of the specificity of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
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7, 14 and 28 days from DOC evaluation
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Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
大体时间：3 months
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Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
大体时间：3 months
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Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
大体时间：3 months
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Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
大体时间：3 months
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Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months
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3 months
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Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
大体时间：3 months
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Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices
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3 months
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Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
大体时间：3 months
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Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
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3 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2020-A00747-32
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