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

Primary Purpose

Comatose, Neurophysiologic Abnormality

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evoked related potential - P3 paradigm
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Comatose focused on measuring DOC patients, ERP (Event related Potentials), Consciousness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GHU Paris Psychiatrie NeurosciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Whole group

Arm 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

Outcomes

Primary Outcome Measures

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)
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)
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)
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)

Secondary Outcome Measures

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)
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)
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)
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)
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
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
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
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
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
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

Full Information

First Posted
March 5, 2021
Last Updated
March 15, 2021
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT04798508
Brief Title
EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
Acronym
EXPRESONREA
Official Title
EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Comatose, Neurophysiologic Abnormality
Keywords
DOC patients, ERP (Event related Potentials), Consciousness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Open and prospective study. Evoked related potentials are recorded for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole group
Arm Type
Other
Arm 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
Intervention Type
Other
Intervention Name(s)
Evoked related potential - P3 paradigm
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
3 months from DOC evaluation
Title
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
Description
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)
Time Frame
3 months from DOC evaluation
Title
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
Description
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)
Time Frame
3 months from DOC evaluation
Title
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
Description
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)
Time Frame
3 months from DOC evaluation
Secondary Outcome Measure Information:
Title
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Description
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)
Time Frame
7, 14 and 28 days from DOC evaluation
Title
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Description
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)
Time Frame
7, 14 and 28 days from DOC evaluation
Title
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
Description
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)
Time Frame
7, 14 and 28 days from DOC evaluation
Title
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Description
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)
Time Frame
7, 14 and 28 days from DOC evaluation
Title
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Description
Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months
Time Frame
3 months
Title
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Description
Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months
Time Frame
3 months
Title
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
Description
Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months
Time Frame
3 months
Title
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Description
Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months
Time Frame
3 months
Title
Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Description
Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices
Time Frame
3 months
Title
Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Description
Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Pruvost-Robieux, MD
Phone
+ 33 1 45 65 81 89
Email
e.pruvost@ghu-paris.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Martine Gavaret, Professor
Phone
+ 33 1 45 65 81 89
Email
m.gavaret@ghu-paris.fr
Facility Information:
Facility Name
GHU Paris Psychiatrie Neurosciences
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Pruvost-Robieux, MD
Phone
+33 1 45 65 81 89
Email
e.pruvost@ghu-paris.fr

12. IPD Sharing Statement

Learn more about this trial

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

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