Recommendations for the use of electroencephalography and evoked potentials in comatose patients.
Nathalie André-Obadia, Julie Zyss, Martine Gavaret...
https://pubmed.ncbi.nlm.nih.gov/29784540Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-12
114
Participants Needed
2
Research Sites
13 weeks
Total Duration
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
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
Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
S
Sarah Benghanem, MD, MSc, PhD student
M
Marie BENHAMMANI-GODARD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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