EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
NCT ID: NCT04798508
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2020-07-30
2022-10-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
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
OTHER
NONE
Study Groups
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Whole group
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
Evoked related potential - P3 paradigm
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
Interventions
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Evoked related potential - P3 paradigm
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Known deafness
* Severe sepsis uncontrolled during neurophysiologic evaluation
18 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Locations
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GHU Paris Psychiatrie Neurosciences
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A00747-32
Identifier Type: -
Identifier Source: org_study_id
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