Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
NCT ID: NCT05740735
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
114 participants
OBSERVATIONAL
2024-03-25
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
NCT04798508
Outcome Prediction in Patients With Acute Disorders of Consciousness
NCT04411719
Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
NCT05802524
Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness
NCT04978857
Voice Analysis in Patients With Neurologic Diseases
NCT04846413
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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)
Use 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).
Disorder of consciousness patients - Retrospective 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Use 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).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sarah Benghanem, MD, MSc, PhD student
Role: PRINCIPAL_INVESTIGATOR
Medical ICU Cochin Hospital, APHP.Centre
Alain Cariou, MD, PhD
Role: STUDY_DIRECTOR
Medical ICU, Cochin Hospital, APHP.Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical ICU, HEGP Hospital, APHP.Centre
Paris, IDF, France
Medical ICU, Cochin Hospital, APHP.Centre
Paris, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sarah BENGHANEM
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-A00607-36
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220568
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.