Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

NCT05740735 | Recruiting

• 2 other identifiers: APHP2205682022-A00607-36
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 2

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.

Conditions

Disorder of Consciousness

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)

Outcome Measures

Primary Outcomes (1)

• 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

  Month 3

Secondary Outcomes (19)

• Glasgow coma scale (GCS)

  Day 7

• Glasgow coma scale (GCS)

  Day 14

• Richmond Agitation-Sedation Scale

  Day 7

• Richmond Agitation-Sedation Scale

  Day 14

• Coma recovery scale-revised CRS-r

  Day 7

Study Arms (2)

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)

Other: Use of "expressive" sounds

Disorder of consciousness patients - Retrospective group

Other: Having benefited from a prognostic evaluation by event related potentials (without sound research methods, only neutral sounds)

Interventions

Use of "expressive" sounds OTHER

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 - Prospective group

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.

Disorder of consciousness patients - Retrospective group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• Moribund patient
• Uncontrolled Shock during the neurophysiological evaluation
• Sedated patient
• Minor patient
• brain death
• Known deafness
• Pregnant woman
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (2)

Medical ICU, HEGP Hospital, APHP.Centre

Paris, IDF, 75015, France

NOT YET RECRUITING

Medical ICU, Cochin Hospital, APHP.Centre

Paris, Île-de-France Region, 75014, France

RECRUITING

Related Publications (11)

• 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.

  PMID: 29784540 BACKGROUND

• 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.

  PMID: 32917521 BACKGROUND

• 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.

  PMID: 18760663 BACKGROUND

• 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.

  PMID: 1978111 BACKGROUND

• 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.

  PMID: 18053971 BACKGROUND

• 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.

  PMID: 16703673 BACKGROUND

• 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.

  PMID: 15792909 BACKGROUND

• 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.

  PMID: 25023618 BACKGROUND

• 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.

  PMID: 35093702 BACKGROUND

• 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.

  PMID: 29421188 BACKGROUND

• 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.

  PMID: 33558510 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Heart Arrest; Coma

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Unconsciousness

Study Officials

• Sarah Benghanem, MD, MSc, PhD student

  Medical ICU Cochin Hospital, APHP.Centre

  PRINCIPAL INVESTIGATOR

• Alain Cariou, MD, PhD

  Medical ICU, Cochin Hospital, APHP.Centre

  STUDY DIRECTOR

Central Study Contacts

Sarah Benghanem, MD, MSc, PhD student

CONTACT

0033158412533; sarah.benghanem@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

0033 1 58411190; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: February 23, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)