Disorder of ConsciousnessExpressComaNCT05740735
Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
An observational study of Disorder of Consciousness, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- Use of "expressive" sounds and Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)
- How many people
- 114 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Mar 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Moribund patient
- Uncontrolled Shock during the neurophysiological evaluation
- Sedated patient
- Minor patient
- brain death
- Known deafness
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Medical ICU, HEGP Hospital, APHP.Centre
Paris, IDF, 75015
Sarah BENGHANEM
Bertrand HERMANN
- Recruiting
Medical ICU, Cochin Hospital, APHP.Centre
Paris, Île-de-France Region, 75014
Sarah Benghanem, MD, MSc, PhD student, 0033158412533, sarah.benghanem@aphp.fr
Marie BENHAMMANI-GODARD, 0033158411190, marie.godard@aphp.fr
About this study
Official title: Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness (DOC)
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.
Read the 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.
- Conditions
- Disorder of Consciousness
- Being tested
- Use of "expressive" sounds, Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)
- 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)
- Medical subject headings
- Consciousness Disorders, Heart Arrest, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of "expressive" soundsOther
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).
Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Disorder of consciousness patients - Prospective group | 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) Receives: Other: Use of "expressive" sounds | |
| Disorder of consciousness patients - Retrospective group | Not described Receives: Other: Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 3
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 6
Mortality
Measured: Day 28
Mortality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start25 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sarah Benghanem, MD, MSc, PhD student, Principal investigator, Medical ICU Cochin Hospital, APHP.CentreAlain Cariou, MD, PhD, Study director, Medical ICU, Cochin Hospital, APHP.Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740735
- Sponsor's protocol ID
- APHP220568
- Other IDs
- 2022-A00607-36
- Acronym
- ExpressComa
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18.
PubMed 29784540Comanducci A, Boly M, Claassen J, De Lucia M, Gibson RM, Juan E, Laureys S, Naccache L, Owen AM, Rosanova M, Rossetti AO, Schnakers C, Sitt JD, Schiff ND, Massimini M. Clinical and advanced neurophysiology in the prognostic and diagnostic evaluation of disorders of consciousness: review of an IFCN-endorsed expert group. Clin Neurophysiol. 2020 Nov;131(11):2736-2765. doi: 10.1016/j.clinph.2020.07.015. Epub 2020 Aug 14.
PubMed 32917521Fischer C, Dailler F, Morlet D. Novelty P3 elicited by the subject's own name in comatose patients. Clin Neurophysiol. 2008 Oct;119(10):2224-30. doi: 10.1016/j.clinph.2008.03.035. Epub 2008 Aug 28.
PubMed 18760663O'Mahony D, Rowan M, Walsh JB, Coakley D. P300 as a predictor of recovery from coma. Lancet. 1990 Nov 17;336(8725):1265-6. doi: 10.1016/0140-6736(90)92887-n. No abstract available.
PubMed 1978111Holeckova I, Fischer C, Morlet D, Delpuech C, Costes N, Mauguiere F. Subject's own name as a novel in a MMN design: a combined ERP and PET study. Brain Res. 2008 Jan 16;1189:152-65. doi: 10.1016/j.brainres.2007.10.091. Epub 2007 Nov 12.
PubMed 18053971Holeckova I, Fischer C, Giard MH, Delpuech C, Morlet D. Brain responses to a subject's own name uttered by a familiar voice. Brain Res. 2006 Apr 12;1082(1):142-52. doi: 10.1016/j.brainres.2006.01.089.
PubMed 16703673Naccache L, Puybasset L, Gaillard R, Serve E, Willer JC. Auditory mismatch negativity is a good predictor of awakening in comatose patients: a fast and reliable procedure. Clin Neurophysiol. 2005 Apr;116(4):988-9. doi: 10.1016/j.clinph.2004.10.009. Epub 2004 Dec 10. No abstract available.
PubMed 15792909Liegeois-Chauvel C, Benar C, Krieg J, Delbe C, Chauvel P, Giusiano B, Bigand E. How functional coupling between the auditory cortex and the amygdala induces musical emotion: a single case study. Cortex. 2014 Nov;60:82-93. doi: 10.1016/j.cortex.2014.06.002. Epub 2014 Jun 16.
PubMed 25023618Pruvost-Robieux E, Andre-Obadia N, Marchi A, Sharshar T, Liuni M, Gavaret M, Aucouturier JJ. It's not what you say, it's how you say it: A retrospective study of the impact of prosody on own-name P300 in comatose patients. Clin Neurophysiol. 2022 Mar;135:154-161. doi: 10.1016/j.clinph.2021.12.015. Epub 2022 Jan 13.
PubMed 35093702Shestopalova LB, Petropavlovskaia EA, Semenova VV, Nikitin NI. Mismatch negativity and psychophysical detection of rising and falling intensity sounds. Biol Psychol. 2018 Mar;133:99-111. doi: 10.1016/j.biopsycho.2018.01.018. Epub 2018 Feb 5.
PubMed 29421188Goupil L, Ponsot E, Richardson D, Reyes G, Aucouturier JJ. Listeners' perceptions of the certainty and honesty of a speaker are associated with a common prosodic signature. Nat Commun. 2021 Feb 8;12(1):861. doi: 10.1038/s41467-020-20649-4.
PubMed 33558510
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness (DOC)
- ClinicalTrials.gov ID
- NCT05740735
- Acronym / sponsor ID
- ExpressComa / APHP220568
- Conditions
- Disorder of Consciousness
- Keywords
- Disorder of consciousness, Cardiac arrest, Coma, Intensive care unit, Neuro-prognostication, Event related potential (ERP), Electroencephalogram (EEG), Emotional sounds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disorder of consciousness patients - Prospective group | – | Other: Use of "expressive" soundsDOC 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 | – | Other: Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- Moribund patient
- Uncontrolled Shock during the neurophysiological evaluation
- Sedated patient
- Minor patient
- brain death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of "expressive" soundsUse 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). | Other | Disorder of consciousness patients - Prospective group |
| Having 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. | Other | Disorder of consciousness patients - Retrospective group |
Primary outcome
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: 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
19 secondary outcomes
Glasgow coma scale (GCS)
Time frame: Day 7
Glasgow coma scale (GCS)
Time frame: Day 14
Richmond Agitation-Sedation Scale
Time frame: Day 7
Richmond Agitation-Sedation Scale
Time frame: Day 14
Coma recovery scale-revised CRS-r
Time frame: Day 7
Coma recovery scale-revised CRS-r
Time frame: Day 14
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Day 28
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Intensive care unit discharge, up to 6 months
Richmond Agitation-Sedation Scale
Time frame: Day 28
Richmond Agitation-Sedation Scale
Time frame: Intensive care unit discharge, up to 6 months
Coma recovery scale-revised CRS-r
Time frame: Day 28
Coma recovery scale-revised CRS-r
Time frame: Intensive care unit discharge, up to 6 months
Glasgow Outcome Scale-Extended (GOS-E)
Time frame: Month 6
Mortality
Time frame: Day 28
Mortality
Time frame: Month 3
P3a amplitudes responses
Time frame: At inclusion
P3a latencies responses
Time frame: At inclusion
MMN amplitudes responses
Time frame: At inclusion
MMN latencies responses
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 29784540Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18.
- Background: PubMed 32917521Comanducci A, Boly M, Claassen J, De Lucia M, Gibson RM, Juan E, Laureys S, Naccache L, Owen AM, Rosanova M, Rossetti AO, Schnakers C, Sitt JD, Schiff ND, Massimini M. Clinical and advanced neurophysiology in the prognostic and diagnostic evaluation of disorders of consciousness: review of an IFCN-endorsed expert group. Clin Neurophysiol. 2020 Nov;131(11):2736-2765. doi: 10.1016/j.clinph.2020.07.015. Epub 2020 Aug 14.
- Background: PubMed 18760663Fischer C, Dailler F, Morlet D. Novelty P3 elicited by the subject's own name in comatose patients. Clin Neurophysiol. 2008 Oct;119(10):2224-30. doi: 10.1016/j.clinph.2008.03.035. Epub 2008 Aug 28.
- Background: PubMed 1978111O'Mahony D, Rowan M, Walsh JB, Coakley D. P300 as a predictor of recovery from coma. Lancet. 1990 Nov 17;336(8725):1265-6. doi: 10.1016/0140-6736(90)92887-n. No abstract available.
- Background: PubMed 18053971Holeckova I, Fischer C, Morlet D, Delpuech C, Costes N, Mauguiere F. Subject's own name as a novel in a MMN design: a combined ERP and PET study. Brain Res. 2008 Jan 16;1189:152-65. doi: 10.1016/j.brainres.2007.10.091. Epub 2007 Nov 12.
- Background: PubMed 16703673Holeckova I, Fischer C, Giard MH, Delpuech C, Morlet D. Brain responses to a subject's own name uttered by a familiar voice. Brain Res. 2006 Apr 12;1082(1):142-52. doi: 10.1016/j.brainres.2006.01.089.
- Background: PubMed 15792909Naccache L, Puybasset L, Gaillard R, Serve E, Willer JC. Auditory mismatch negativity is a good predictor of awakening in comatose patients: a fast and reliable procedure. Clin Neurophysiol. 2005 Apr;116(4):988-9. doi: 10.1016/j.clinph.2004.10.009. Epub 2004 Dec 10. No abstract available.
- Background: PubMed 25023618Liegeois-Chauvel C, Benar C, Krieg J, Delbe C, Chauvel P, Giusiano B, Bigand E. How functional coupling between the auditory cortex and the amygdala induces musical emotion: a single case study. Cortex. 2014 Nov;60:82-93. doi: 10.1016/j.cortex.2014.06.002. Epub 2014 Jun 16.
- Background: PubMed 35093702Pruvost-Robieux E, Andre-Obadia N, Marchi A, Sharshar T, Liuni M, Gavaret M, Aucouturier JJ. It's not what you say, it's how you say it: A retrospective study of the impact of prosody on own-name P300 in comatose patients. Clin Neurophysiol. 2022 Mar;135:154-161. doi: 10.1016/j.clinph.2021.12.015. Epub 2022 Jan 13.
- Background: PubMed 29421188Shestopalova LB, Petropavlovskaia EA, Semenova VV, Nikitin NI. Mismatch negativity and psychophysical detection of rising and falling intensity sounds. Biol Psychol. 2018 Mar;133:99-111. doi: 10.1016/j.biopsycho.2018.01.018. Epub 2018 Feb 5.
- Background: PubMed 33558510Goupil L, Ponsot E, Richardson D, Reyes G, Aucouturier JJ. Listeners' perceptions of the certainty and honesty of a speaker are associated with a common prosodic signature. Nat Commun. 2021 Feb 8;12(1):861. doi: 10.1038/s41467-020-20649-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Benghanem, MD, MSc, PhD student principal investigator
Medical ICU Cochin Hospital, APHP.Centre
Alain Cariou, MD, PhD study director
Medical ICU, Cochin Hospital, APHP.Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Benghanem, MD, MSc, PhD student (0033158412533, sarah.benghanem@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale-Extended (GOS-E) (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05740735, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.