Studies
| Study First Submitted Date | 2022-09-06 |
| Study First Posted Date | 2023-02-23 |
| Last Update Posted Date | 2023-02-23 |
| Start Month Year | March 2023 |
| Primary Completion Month Year | June 2025 |
| Verification Month Year | February 2023 |
| Verification Date | 2023-02-28 |
| Last Update Posted Date | 2023-02-23 |
Detailed Descriptions
| Sequence: | 20663908 |
| 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. |
Facilities
| Sequence: | 199451591 |
| Name | Medical ICU, Cochin Hospital, APHP.Centre |
| City | Paris |
| State | Ile De France |
| Zip | 75014 |
| Country | France |
Facility Contacts
| Sequence: | 28030474 | Sequence: | 28030475 |
| Facility Id | 199451591 | Facility Id | 199451591 |
| Contact Type | primary | Contact Type | backup |
| Name | Sarah Benghanem, MD, MSc, PhD student | Name | Marie BENHAMMANI-GODARD |
| [email protected] | [email protected] | ||
| Phone | 0033158412533 | Phone | 0033158411190 |
Conditions
| Sequence: | 52020397 |
| Name | Disorder of Consciousness |
| Downcase Name | disorder of consciousness |
Id Information
| Sequence: | 40040473 | Sequence: | 40040474 |
| Id Source | org_study_id | Id Source | secondary_id |
| Id Value | APHP220568 | Id Value | 2022-A00607-36 |
| Id Type | Other Identifier | ||
| Id Type Description | France : ANSM | ||
Countries
| Sequence: | 42436889 |
| Name | France |
| Removed | False |
Design Groups
| Sequence: | 55427508 |
| Title | Disorder of consciousness patients |
| Description | 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) |
Interventions
| Sequence: | 52333010 |
| Intervention Type | Other |
| Name | Use of "expressive" sounds |
| Description | 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). |
Keywords
| Sequence: | 79626085 | Sequence: | 79626086 | Sequence: | 79626087 | Sequence: | 79626088 | Sequence: | 79626089 | Sequence: | 79626090 | Sequence: | 79626091 | Sequence: | 79626092 | Sequence: | 79626093 | Sequence: | 79626094 | Sequence: | 79626095 |
| Name | Disorder of consciousness | Name | Cardiac arrest | Name | Coma | Name | Intensive care unit | Name | Neuro-prognostication | Name | Event related potential (ERP) | Name | Electroencephalogram (EEG) | Name | Emotional sounds | Name | Subject own name (SON) | Name | P300 | Name | Mismatch negativity (MMN) |
| Downcase Name | disorder of consciousness | Downcase Name | cardiac arrest | Downcase Name | coma | Downcase Name | intensive care unit | Downcase Name | neuro-prognostication | Downcase Name | event related potential (erp) | Downcase Name | electroencephalogram (eeg) | Downcase Name | emotional sounds | Downcase Name | subject own name (son) | Downcase Name | p300 | Downcase Name | mismatch negativity (mmn) |
Design Outcomes
| Sequence: | 176854624 | Sequence: | 176854625 | Sequence: | 176854626 | Sequence: | 176854627 | Sequence: | 176854628 | Sequence: | 176854629 | Sequence: | 176854630 | Sequence: | 176854631 | Sequence: | 176854632 | Sequence: | 176854633 | Sequence: | 176854634 | Sequence: | 176854635 | Sequence: | 176854636 | Sequence: | 176854637 | Sequence: | 176854638 | Sequence: | 176854639 | Sequence: | 176854640 | Sequence: | 176854641 | Sequence: | 176854642 | Sequence: | 176854643 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Glasgow Outcome Scale-Extended (GOS-E) | Measure | Glasgow coma scale (GCS) | Measure | Glasgow coma scale (GCS) | Measure | Richmond Agitation-Sedation Scale | Measure | Richmond Agitation-Sedation Scale | Measure | Coma recovery scale-revised CRS-r | Measure | Coma recovery scale-revised CRS-r | Measure | Glasgow Outcome Scale-Extended (GOS-E) | Measure | Glasgow Outcome Scale-Extended (GOS-E) | Measure | Richmond Agitation-Sedation Scale | Measure | Richmond Agitation-Sedation Scale | Measure | Coma recovery scale-revised CRS-r | Measure | Coma recovery scale-revised CRS-r | Measure | Glasgow Outcome Scale-Extended (GOS-E) | Measure | Mortality | Measure | Mortality | Measure | P3a amplitudes responses | Measure | P3a latencies responses | Measure | MMN amplitudes responses | Measure | MMN latencies responses |
| Time Frame | Month 3 | Time Frame | Day 7 | Time Frame | Day 14 | Time Frame | Day 7 | Time Frame | Day 14 | Time Frame | Day 7 | Time Frame | Day 14 | Time Frame | Day 28 | Time Frame | Intensive care unit discharge, up to 6 months | Time Frame | Day 28 | Time Frame | Intensive care unit discharge, up to 6 months | Time Frame | Day 28 | Time Frame | Intensive care unit discharge, up to 6 months | Time Frame | Month 6 | Time Frame | Day 28 | Time Frame | Month 3 | Time Frame | At inclusion | Time Frame | At inclusion | Time Frame | At inclusion | Time Frame | At inclusion |
| Description | 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 | Description | 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 | Description | 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 | Description | 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 | Description | 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 | Description | Level of awareness – From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence | Description | Level of awareness – From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence | Description | 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 | Description | 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 | Description | 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 | Description | 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 | Description | Neurological outcome – From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence | Description | Neurological outcome – From 0 to 23 : 0 to 7 = vegetative state, 8 to 15 = minimal conscious state, 16-23 = minimal conscious state emergence | Description | 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 | Description | 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 | Description | 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 | Description | 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 | Description | 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 |
Browse Conditions
| Sequence: | 192888979 | Sequence: | 192888980 | Sequence: | 192888981 | Sequence: | 192888982 | Sequence: | 192888983 | Sequence: | 192888984 |
| Mesh Term | Consciousness Disorders | Mesh Term | Neurobehavioral Manifestations | Mesh Term | Neurologic Manifestations | Mesh Term | Nervous System Diseases | Mesh Term | Neurocognitive Disorders | Mesh Term | Mental Disorders |
| Downcase Mesh Term | consciousness disorders | Downcase Mesh Term | neurobehavioral manifestations | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | neurocognitive disorders | Downcase Mesh Term | mental disorders |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48178744 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Assistance Publique – Hôpitaux de Paris |
Overall Officials
| Sequence: | 29198658 | Sequence: | 29198659 |
| Role | Principal Investigator | Role | Study Director |
| Name | Sarah Benghanem, MD, MSc, PhD student | Name | Alain Cariou, MD, PhD |
| Affiliation | Medical ICU Cochin Hospital, APHP.Centre | Affiliation | Medical ICU, Cochin Hospital, APHP.Centre |
Central Contacts
| Sequence: | 11975241 | Sequence: | 11975242 |
| Contact Type | primary | Contact Type | backup |
| Name | Sarah Benghanem, MD, MSc, PhD student | Name | Marie BENHAMMANI-GODARD |
| Phone | 0033158412533 | Phone | 0033 1 58411190 |
| [email protected] | [email protected] | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 67948167 |
| Design Group Id | 55427508 |
| Intervention Id | 52333010 |
Eligibilities
| Sequence: | 30677120 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | All patients admitted to Cochin Hospital ICU with a primary brain injury (after CA, TBI, stroke) and a persistent DOC (coma, VS, MCS) 48 to 96 hours after sedation discontinuation. |
| Criteria | Inclusion Criteria: patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage or head trauma, persistent disorder of consciousness (DOC) 48 to 96 hours after sedation weaning Exclusion Criteria: Moribund patients Uncontrolled Shock during the neurophysiological evaluation Sedated patients Minor patients brain death Known deafness Pregnant women Prior inclusion in the study Patients not affiliated to a social security system Implementation of limitations and stop of active therapies Patients under legal protection Patients benefiting from State Medical Aid |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253870442 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 19 |
Designs
| Sequence: | 30423873 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28790394 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51910015 | Sequence: | 51910016 | Sequence: | 51910017 | Sequence: | 51910018 | Sequence: | 51910019 | Sequence: | 51910020 | Sequence: | 51910021 | Sequence: | 51910022 | Sequence: | 51910023 | Sequence: | 51910024 | Sequence: | 51910025 |
| Pmid | 29784540 | Pmid | 32917521 | Pmid | 18760663 | Pmid | 1978111 | Pmid | 18053971 | Pmid | 16703673 | Pmid | 15792909 | Pmid | 25023618 | Pmid | 35093702 | Pmid | 29421188 | Pmid | 33558510 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | 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. | Citation | Comanducci 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. | Citation | Fischer 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. | Citation | O'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. | Citation | Holeckova 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. | Citation | Holeckova 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. | Citation | Naccache 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. | Citation | Liegeois-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. | Citation | Pruvost-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. | Citation | Shestopalova 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. | Citation | Goupil 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. Erratum In: Nat Commun. 2021 Sep 27;12(1):5781. |