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Emotion Assessment to Study Consciousness in Awakening Patients (EmotiCones)

Primary Purpose

Persistent Vegetative State

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physiological recording in response to different types of stimuli
EEG recording in response to different types of stimuli
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Vegetative State focused on measuring Persistent Vegetative State, minimally conscious state, Emotions, Awareness, electrodermal activity, Electroencephalography

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For Patients :

  • age between 18 and 80
  • acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month
  • level of consciousness assessed with the coma recovery scale revised (CRS-R)
  • patient with health insurance
  • informed consent signed by the patients or his representative

For Healthy participants:

  • age between 18 and 80
  • participant able to understand instructions and normal hearing
  • patient with health insurance
  • informed consent signed

Exclusion Criteria:

For Patients :

  • non controlled epilepsy
  • dysautonomic crisis
  • unstable medical state
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship

For Healthy participants:

  • neurological disorder
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty

Sites / Locations

  • Hospices Civils de LyonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Vegetative State

Minimally Conscious State

Acquired Brain damaged patients without DOC

Healthy subjects

Arm Description

For patients in vegetative state (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

For patients in minimally conscious state (n = 15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

Acquired Brain damaged patients without disorder of consciousness (patients without DOC) For patients with acquired brain damage without disorder of consciousness (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography

For healthy subjects (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

Outcomes

Primary Outcome Measures

electrodermal response
skin conductance response measured with trans-cutaneus electrodes

Secondary Outcome Measures

pupillary response
use of eye-tracker
heart rate modification
use of transcutaneous electrode
Variation of the intensity of different Event Related Potentials
electroencephalography (EEG) The investigator will study how the intensity of different Event Related Potentials varies with different levels of sound around the auditory threshold: this will be assessed specifically for early cortical components of the auditory response such as the N1 around 100 ms after the stimulus, and for late components around 300-500 ms after the stimulus, particularly the P300.

Full Information

First Posted
October 8, 2018
Last Updated
January 16, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03706170
Brief Title
Emotion Assessment to Study Consciousness in Awakening Patients
Acronym
EmotiCones
Official Title
Emotion Assessment to Study Consciousness in Awakening Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

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
After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious. The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness. The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience. In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Vegetative State
Keywords
Persistent Vegetative State, minimally conscious state, Emotions, Awareness, electrodermal activity, Electroencephalography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vegetative State
Arm Type
Experimental
Arm Description
For patients in vegetative state (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.
Arm Title
Minimally Conscious State
Arm Type
Experimental
Arm Description
For patients in minimally conscious state (n = 15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.
Arm Title
Acquired Brain damaged patients without DOC
Arm Type
Experimental
Arm Description
Acquired Brain damaged patients without disorder of consciousness (patients without DOC) For patients with acquired brain damage without disorder of consciousness (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
For healthy subjects (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.
Intervention Type
Behavioral
Intervention Name(s)
Physiological recording in response to different types of stimuli
Intervention Description
In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.
Intervention Type
Behavioral
Intervention Name(s)
EEG recording in response to different types of stimuli
Intervention Description
In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.
Primary Outcome Measure Information:
Title
electrodermal response
Description
skin conductance response measured with trans-cutaneus electrodes
Time Frame
at Day 1
Secondary Outcome Measure Information:
Title
pupillary response
Description
use of eye-tracker
Time Frame
at Day 1
Title
heart rate modification
Description
use of transcutaneous electrode
Time Frame
at day 1
Title
Variation of the intensity of different Event Related Potentials
Description
electroencephalography (EEG) The investigator will study how the intensity of different Event Related Potentials varies with different levels of sound around the auditory threshold: this will be assessed specifically for early cortical components of the auditory response such as the N1 around 100 ms after the stimulus, and for late components around 300-500 ms after the stimulus, particularly the P300.
Time Frame
at Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For Patients : age between 18 and 80 acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month level of consciousness assessed with the coma recovery scale revised (CRS-R) patient with health insurance informed consent signed by the patients or his representative For Healthy participants: age between 18 and 80 participant able to understand instructions and normal hearing patient with health insurance informed consent signed Exclusion Criteria: For Patients : non controlled epilepsy dysautonomic crisis unstable medical state pregnancy or breath feeding for women Persons under guardianship, curatorship For Healthy participants: neurological disorder pregnancy or breath feeding for women Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques LUAUTE, MD
Phone
478865023
Ext
+33
Email
jacques.luaute@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
Phone
478865023
Ext
+33
Email
jacques.luaute@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jacques LUAUTE, MD
First Name & Middle Initial & Last Name & Degree
Mathilde LUCAS, MD
First Name & Middle Initial & Last Name & Degree
Damien WAZ, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotion Assessment to Study Consciousness in Awakening Patients

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