Actively Recruiting

Age: 18Years +
All Genders
ID05740735

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12

114

Participants Needed

2

Research Sites

13 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how emotional sounds, specifically a person's own name spoken by a familiar voice, compared to the same name spoken by an unfamiliar voice, affect brain responses called P300 in critically ill patients with disorders of consciousness (DOC). These patients have brain injuries due to causes such as cardiac arrest, stroke, or trauma. The study aims to see if these emotional sounds provide a more reliable way to predict neurological recovery in intensive care unit (ICU) patients. Participants will be exposed to different auditory stimuli including their own first name spoken by a familiar voice to generate P300 responses and sounds with a three-dimensional effect like "approaching" sounds to produce mismatch negativity (MMN) responses. The study includes a prospective group of DOC patients and a retrospective group who previously had neurophysiological assessments with only neutral sounds. The researchers will compare brain responses to emotional and neutral sounds to evaluate their prognostic value. During the study, patients will undergo neurophysiological evaluations measuring brain activity through event-related potentials. Outcomes like the Glasgow Outcome Scale-Extended (GOS-E) at 3 months and several secondary measures including coma scales and agitation-sedation scales will be monitored over various timepoints up to 6 months. Researchers will analyze brain responses at inclusion and track clinical progress using standardized neurological scales to assess recovery and prognosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage, or head trauma
  • Persistent disorder of consciousness 12 hours after sedation weaning
  • Patients who had a prognostic assessment with late PEA including MMN and P300 responses to neutral sounds more than 6 months ago (since April 2022)
Not Eligible

You will not qualify if you...

  • Moribund patients
  • Patients in uncontrolled shock during 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
  • Patients with limitations or stop of active therapies
  • Patients under legal protection
  • Patients benefiting from State Medical Aid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants undergo neurophysiological assessments using event-related potentials with exposure to emotional and neutral sounds to evaluate brain responses.

1 visit (in-person)

Monitoring

Duration - Up to 6 months

Participants are monitored over time for neurological outcomes and recovery status using clinical scales and neurophysiological measures.

Visits on Days 7, 14, 28 and Months 3 and 6

Trial Site Locations

Total: 2 locations

1

Medical ICU, HEGP Hospital, APHP.Centre

Paris, IDF, France, 75015

Not Yet Recruiting

2

Medical ICU, Cochin Hospital, APHP.Centre

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

Actively Recruiting

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Research Team

S

Sarah Benghanem, MD, MSc, PhD student

M

Marie BENHAMMANI-GODARD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Clinical and advanced neurophysiology in the prognostic and diagnostic evaluation of disorders of consciousness: review of an IFCN-endorsed expert group.

A Comanducci, M Boly, J Claassen...

https://pubmed.ncbi.nlm.nih.gov/32917521

Auditory mismatch negativity is a good predictor of awakening in comatose patients: a fast and reliable procedure.

Lionel Naccache, Louis Puybasset, Raphaël Gaillard...

https://pubmed.ncbi.nlm.nih.gov/15792909

How functional coupling between the auditory cortex and the amygdala induces musical emotion: a single case study.

Catherine Liégeois-Chauvel, Christian Bénar, Julien Krieg...

https://pubmed.ncbi.nlm.nih.gov/25023618

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.

Estelle Pruvost-Robieux, Nathalie André-Obadia, Angela Marchi...

https://pubmed.ncbi.nlm.nih.gov/35093702

Mismatch negativity and psychophysical detection of rising and falling intensity sounds.

Lidia B Shestopalova, Ekaterina A Petropavlovskaia, Varvara V Semenova...

https://pubmed.ncbi.nlm.nih.gov/29421188