Viewing Study NCT04798508



Ignite Creation Date: 2024-05-06 @ 3:53 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04798508
Status: UNKNOWN
Last Update Posted: 2021-03-17
First Post: 2021-03-05

Brief Title: EXPRE-SON-REA Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
Sponsor: Centre Hospitalier St Anne
Organization: Centre Hospitalier St Anne

Study Overview

Official Title: EXPRE-SON-REA Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXPRESONREA
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None