Clinical trial NCT04798508: EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
Official title: EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comatose
Neurophysiologic Abnormality
Keywords: DOC patients
ERP (Event related Potentials)
Consciousness
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 months from DOC evaluation
measure: 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
timeFrame: 3 months from DOC evaluation
measure: 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
timeFrame: 3 months from DOC evaluation
measure: 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
timeFrame: 3 months from DOC evaluation
Secondary outcomes:
measure: Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
timeFrame: 7, 14 and 28 days from DOC evaluation
measure: Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
timeFrame: 7, 14 and 28 days from DOC evaluation
measure: Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
timeFrame: 7, 14 and 28 days from DOC evaluation
measure: Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
timeFrame: 7, 14 and 28 days from DOC evaluation
measure: Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
timeFrame: 3 months
measure: Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
timeFrame: 3 months
measure: Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
timeFrame: 3 months
measure: Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
timeFrame: 3 months
measure: Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
timeFrame: 3 months
measure: Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Paris Psychiatrie Neurosciences
Study officials:
References: