Clinical Trials Directory

Trials / Unknown

UnknownNCT04798508

EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients

EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
78 (estimated)
Sponsor
Centre Hospitalier St Anne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units. Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm. Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.

Detailed description

Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC. In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing. Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.

Conditions

Interventions

TypeNameDescription
OTHEREvoked related potential - P3 paradigmEvoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice

Timeline

Start date
2020-07-30
Primary completion
2022-07-30
Completion
2022-10-30
First posted
2021-03-15
Last updated
2021-03-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04798508. Inclusion in this directory is not an endorsement.