Clinical trial NCT05740735: Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
Official title: Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness (DOC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disorder of Consciousness
Keywords: Disorder of consciousness
Cardiac arrest
Coma
Intensive care unit
Neuro-prognostication
Event related potential (ERP)
Electroencephalogram (EEG)
Emotional sounds
Subject own name (SON)
P300
Mismatch negativity (MMN)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to Cochin Hospital ICU with a primary brain injury (after CA, TBI, stroke) and a persistent DOC (coma, VS, MCS) 12 hours after sedation discontinuation.

Brief summary: The purpose of this study is to determine if the use of emotional sound as subject own name (SON) pronounced by a familiar voice (FV) compared to SON pronounced by a non-familiar voice (NFV) during event related potential (ERP) produced a more reliable neurophysiological P300 responses, and to assess the prognostic value of this P300 responses induced by the SON with a FV.

Detailed description: The evaluation of the neurological outcome of intensive care unit (ICU) patients with a disorder of consciousness (DOC) is a major medical, ethical and economic issue. These DOC are essentially related to a direct anoxo-ischaemic (post-cardiac arrest), traumatic or even vascular (caused by a hemorrhagic or ischemic vascular accident) cerebral aggression. The techniques currently available, whether neurophysiological (electroencephalogram (EEG) and evoked potentials (EP)), neuroradiological or biological, only allow an approximate evaluation for a large number of aetiologies and patients (Obadi. EEG and EPs have the advantage of being feasible at the patient's bedside, with a precise spatial-temporal resolution of the cerebral capacities to integrate sensory stimulation. If some neurophysiological tests have an imperfect predictive capacity, event-related potentials, (ERPs) with "oddball paradigm" seem to be a promising method. During their realizations by exposing the subject to listening to a deviant and rare auditory stimulus within other frequent stimuli, a first neurophysiological response is generated 150 to 200ms after the stimulation called "mismatch negativity" (MMN), then a second response to 300ms of stimulation called "P3a" is generated. The latter would reflect the orientation of a subject's attention towards the deviant stimulus and could predict arousal.

Some recent data report that a P3 response obtained by exposing the subject to a stimulus with expressive and emotional value, such as the patient's own first name, could improve the prognostic value of this neurophysiological tool (Fischer et al, Holeckova et al). Indeed, the neural processing of expressive voices involves a greater number of subcortical and cortical regions than neutral sounds (Schirmer and Kotz). Moreover, some data suggest that the use of a "subject own name" (SON) auditory stimulus pronounced by a familiar voice (FV) compared to an unfamiliar voice (NFV) could improve the prognostic value of P3 or even the use binaural sounds with a three-dimensional effect as "looming" or "receding" sounds, these hypotheses having never been evaluated in DOC patients.

The investigators hypothesize that cortical and subcortical activation is more complex and intense in response to emotional than to neutral sounds, and that obtaining a P3a response generated by sounds expressive type SON pronounced by a familiar voice (FV) would have a prognostic value greater than the P3 response induced by the SON with an unfamiliar voice for wakefulness prediction of DOC patients; The investigators will also test the hypothesis that the prognostic value of the MMN response generated by sounds with randomly varied motion in their 3D auditory field (e.g. looming or receding sources) is higher than those generated by neutral sounds.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage or head trauma,
* persistent disorder of consciousness (DoC) 12 hours after sedation weaning or patient who has benefited from a prognostic assessment for persistent DoC and who has had in this assessment an evaluation by late PEA with MMN and P300 responses only to neutral sounds ("beep" and patient's first name pronounced by an unfamiliar voice) there is more than 6 months (since April 2022)

Exclusion Criteria:

* Moribund patient
* Uncontrolled Shock during the neurophysiological evaluation
* Sedated patient
* Minor patient
* brain death
* Known deafness
* Pregnant woman
* Prior inclusion in the study
* Patient not affiliated to a social security system
* Implementation of limitations and stop of active therapies
* Patient under legal protection
* Patient benefiting from State Medical Aid

Primary outcomes:
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 3
Secondary outcomes:
measure: Glasgow coma scale (GCS)
timeFrame: Day 7
measure: Glasgow coma scale (GCS)
timeFrame: Day 14
measure: Richmond Agitation-Sedation Scale
timeFrame: Day 7
measure: Richmond Agitation-Sedation Scale
timeFrame: Day 14
measure: Coma recovery scale-revised CRS-r
timeFrame: Day 7
measure: Coma recovery scale-revised CRS-r
timeFrame: Day 14
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Day 28
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Intensive care unit discharge, up to 6 months
measure: Richmond Agitation-Sedation Scale
timeFrame: Day 28
measure: Richmond Agitation-Sedation Scale
timeFrame: Intensive care unit discharge, up to 6 months
measure: Coma recovery scale-revised CRS-r
timeFrame: Day 28
measure: Coma recovery scale-revised CRS-r
timeFrame: Intensive care unit discharge, up to 6 months
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: Month 6
measure: Mortality
timeFrame: Day 28
measure: Mortality
timeFrame: Month 3
measure: P3a amplitudes responses
timeFrame: At inclusion
measure: P3a latencies responses
timeFrame: At inclusion
measure: MMN amplitudes responses
timeFrame: At inclusion
measure: MMN latencies responses
timeFrame: At inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Medical ICU, HEGP Hospital, APHP.Centre
state: IDF
city: Paris
country: France
facility: Medical ICU, Cochin Hospital, APHP.Centre
state: Ile de France
Study officials:
affiliation: Medical ICU Cochin Hospital, APHP.Centre
name: Sarah Benghanem, MD, MSc, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical ICU, Cochin Hospital, APHP.Centre
name: Alain Cariou, MD, PhD
role: STUDY_DIRECTOR
References:
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