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

Centre Hospitalier St Anne

Status: Unknown

Conditions: Comatose; Neurophysiologic Abnormality

Treatments: Other: Evoked related potential - P3 paradigm

Study type: Interventional

Funder types: Other

Identifiers

NCT04798508

2020-A00747-32

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18
• Disorder of consciousness defined as :

Glasgow coma scale < 8 or >8 but

• eyes opening to pain only
• No response to basic command
• Available neuro-imagery (CT-scan or MRI)
• Normal temperature (no fever or hypothermia)
• Normal blood pressure during neurophysiologic evaluation
• Given consent from relatives

Exclusion criteria

• Brain death
• Known deafness
• Severe sepsis uncontrolled during neurophysiologic evaluation

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Whole group

Other group

Description:

The whole group listen successively the 3 paradigms : * P3 own-name recorded by listening to a smiling voice * P3 own-name recorded by listening to a neutral voice * P3 own-name recorded by listening to a rough voice

Treatment:

Other: Evoked related potential - P3 paradigm