Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
- Conditions
- Disorder of Consciousness
- Interventions
- Other: Use of "expressive" soundsOther: Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)
- Registration Number
- NCT05740735
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 114
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Disorder of consciousness patients - Prospective group Use of "expressive" sounds 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) Disorder of consciousness patients - Retrospective group Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds) -
- Primary Outcome Measures
Name Time Method Glasgow Outcome Scale-Extended (GOS-E) Month 3 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
- Secondary Outcome Measures
Name Time Method Mortality Month 3 Glasgow coma scale (GCS) Day 14 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
Richmond Agitation-Sedation Scale Intensive care unit discharge, up to 6 months 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
Coma recovery scale-revised CRS-r Intensive care unit discharge, up to 6 months Neurological outcome - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence
Glasgow Outcome Scale-Extended (GOS-E) Month 6 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
P3a amplitudes responses At inclusion 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
P3a latencies responses At inclusion 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
MMN amplitudes responses At inclusion 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
MMN latencies responses At inclusion 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
Trial Locations
- Locations (2)
Medical ICU, HEGP Hospital, APHP.Centre
🇫🇷Paris, IDF, France
Medical ICU, Cochin Hospital, APHP.Centre
🇫🇷Paris, Ile De France, France