An observational study in Disorder of Consciousness, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.
This study's planned enrollment of 114 is above the median of 79 across 95 observational studies indexed under Consciousness Disorders.
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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.
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Exclusion Criteria:
DOC defined either by a coma (Glasgow Coma Scale \<8), a vegetative state (VS) or a minimal state of consciousness (MCS) according to the Coma recovery scale-revised (CRS-r) after a primary brain injury: severe traumatic brain injury (TBI)), subarachnoid hemorrhage, stroke or cardiac arrest (CA)
Other: Use of "expressive" sounds
Other: Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)
Use of "expressive" sounds, that is to say the own first name pronounced by the voice of the relative to generate the P300 and a sound with an "approaching" character of the subject to generate the MMN. The investigators will thus be able to compare: * MMN: present/absent for each modality (neutral vs approaching sounds) * Wave P3a: latencies and amplitudes for each modality (own first name voice of the near vs unfamiliar).
Retrospective inclusion Have already had an assessment with event related potentials without "emotional" modalities (VF and similar sounds) as part of their care between April 2022 and December 2022 in intensive care at Cochin hospital.
Glasgow Outcome Scale-Extended (GOS-E)
Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death
Time frame: Month 3
Glasgow coma scale (GCS)
Level of awareness - From 3 to 15 : Score of 3 to 8 defined comatose state, score 9 to 14 defined alteration of awareness or confusion and score 15 defined conscious and not confuse patients
Time frame: Day 7
Glasgow coma scale (GCS)
Level of awareness - From 3 to 15 : Score of 3 to 8 defined comatose state, score 9 to 14 defined alteration of awareness or confusion and score 15 defined conscious and not confuse patients
Time frame: Day 14
Richmond Agitation-Sedation Scale
Level of awareness - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable
Time frame: Day 7
Richmond Agitation-Sedation Scale
Level of awareness - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable
Time frame: Day 14
Coma recovery scale-revised CRS-r
Level of awareness - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence
Time frame: Day 7
Coma recovery scale-revised CRS-r
Level of awareness - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence
Time frame: Day 14
Glasgow Outcome Scale-Extended (GOS-E)
Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death
Time frame: Day 28
Glasgow Outcome Scale-Extended (GOS-E)
Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death
Time frame: Intensive care unit discharge, up to 6 months
Richmond Agitation-Sedation Scale
Neurological outcome - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable
Time frame: Day 28
Richmond Agitation-Sedation Scale
Neurological outcome - From -5 to + 4 : +4 = Combative Overtly combative, violent, immediate danger to staff / +3 = Very agitated Pulls or removes tube(s) or catheter(s); aggressive / +2 = Agitated Frequent non-purposeful movement, fights ventilator / +1 = Restless Anxious but movements not aggressive vigorous / 0 = Alert and calm / -1 = Drowsy Not fully alert, but has sustained awakening / (eye-opening/eye contact) to voice (\>10 seconds) / -2 = Light sedation Briefly awakens with eye contact to voice (\<10 seconds) / -3 = Moderate sedation Movement or eye opening to voice (but no eye contact) / -4 = Deep sedation No response to voice, but movement or eye opening to physical stimulation / -5 = Unarousable
Time frame: Intensive care unit discharge, up to 6 months
Coma recovery scale-revised CRS-r
Neurological outcome - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence
Time frame: Day 28
Coma recovery scale-revised CRS-r
Neurological outcome - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence
Time frame: Intensive care unit discharge, up to 6 months
Glasgow Outcome Scale-Extended (GOS-E)
Neurological outcome - From 1 to 8 : 8 = Good Recovery - higher level / 7 = Good Recovery - lower level / 6 = Moderate disability - higher level / 5 = Moderate disability - lower level / 4 = Severe disability - higher level / 3 l= Severe disability - lower level / 2 = Persistent vegetative state / 1 = Death
Time frame: Month 6
Mortality
Time frame: Day 28
Mortality
Time frame: Month 3
P3a amplitudes responses
Neurophysiological characteristics of the P3a response to different stimuli (FV vs NFV) / Comparison of the P3a amplitudes and latencies responses according to the different stimuli
Time frame: At inclusion
P3a latencies responses
Neurophysiological characteristics of the P3a response to different stimuli (FV vs NFV) / Comparison of the P3a amplitudes and latencies responses according to the different stimuli
Time frame: At inclusion
MMN amplitudes responses
Neurophysiological characteristics of the MMN response to the different stimuli (looming or receding sources) / Comparison of the MMN amplitudes and latencies responses according to the different stimuli
Time frame: At inclusion
MMN latencies responses
Neurophysiological characteristics of the MMN response to the different stimuli (looming or receding sources) / Comparison of the MMN amplitudes and latencies responses according to the different stimuli
Time frame: At inclusion
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