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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Comatose; Neurophysiologic Abnormality
• Intervention / Treatment: Other: Evoked related potential - P3 paradigm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Estelle Pruvost-Robieux, MD; Phone Number: + 33 1 45 65 81 89; Email: e.pruvost@ghu-paris.fr
• Study Contact Backup: Name: Martine Gavaret, Professor; Phone Number: + 33 1 45 65 81 89; Email: m.gavaret@ghu-paris.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • GHU Paris Psychiatrie Neurosciences
    • Contact: Estelle Pruvost-Robieux, MD; Phone Number: +33 1 45 65 81 89; Email: e.pruvost@ghu-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Whole group; 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	Other: Evoked related potential - P3 paradigm; Evoked 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months	Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)	3 months from DOC evaluation
Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months	Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)	3 months from DOC evaluation
Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months	Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)	3 months from DOC evaluation
Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months	Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)	3 months from DOC evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	Determination of the negative predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)	7, 14 and 28 days from DOC evaluation
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	Determination of the positive predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)	7, 14 and 28 days from DOC evaluation
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale	Determination of the sensibility of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)	7, 14 and 28 days from DOC evaluation
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale	Determination of the specificity of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)	7, 14 and 28 days from DOC evaluation
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening	Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening	Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months	3 months
Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.	Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices	3 months
Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.	Latencies of P3a waves recorded with own name uttered by expressive and neutral voices	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Consciousness; DOC patients; ERP (Event related Potentials)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma
• Other Study ID Numbers: 2020-A00747-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No