Disorder of Consciousness
Conditions
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)
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.
Interventions
OTHERUse of expressive 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).
OTHERHaving benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)
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.
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Glasgow coma scale (GCS) | Day 7 | 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 | Day 7 | 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 |
| 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 |
| Coma recovery scale-revised CRS-r | Day 7 | Level of awareness - From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence |
| Mortality | Day 28 | — |
| 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 |
| Glasgow Outcome Scale-Extended (GOS-E) | Day 28 | 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 |
Countries
France
Contacts
Primary ContactSarah Benghanem, MD, MSc, PhD student
Backup ContactMarie BENHAMMANI-GODARD
Outcome results
None listed