EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.

Conditions
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Comatose, Neurophysiologic Abnormality

Intervention / Treatment
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* Other: Evoked related potential - P3 paradigm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Open and prospective study. Evoked related potentials are recorded for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Whole group<br>The whole group listen successively the 3 paradigms : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice | Other: Evoked related potential - P3 paradigm<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 3 months from DOC evaluation | 
| 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 | 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) | 3 months from DOC evaluation | 
| 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 | 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) | 3 months from DOC evaluation | 
| 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 | 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) | 3 months from DOC evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale | 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) | 7, 14 and 28 days from DOC evaluation | 
| Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale | 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) | 7, 14 and 28 days from DOC evaluation | 
| Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale | 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) | 7, 14 and 28 days from DOC evaluation | 
| Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale | 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) | 7, 14 and 28 days from DOC evaluation | 
| Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening | Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months | 3 months | 
| Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening | Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months | 3 months | 
| Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening | Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months | 3 months | 
| Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening | Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months | 3 months | 
| Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices. | Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices | 3 months | 
| Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices. | Latencies of P3a waves recorded with own name uttered by expressive and neutral voices | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DOC patients, ERP (Event related Potentials), Consciousness