Emotion Assessment to Study Consciousness in Awakening Patients (EmotiCones)

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).

Study Overview

• Status: Recruiting
• Conditions: Persistent Vegetative State
• Intervention / Treatment: Behavioral: Physiological recording in response to different types of stimuli; Behavioral: EEG recording in response to different types of stimuli

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques LUAUTE, MD; Phone Number: +33 478865023; Email: jacques.luaute@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Jacques LUAUTE, MD; Phone Number: +33 478865023; Email: jacques.luaute@chu-lyon.fr
    • Principal Investigator: Jacques LUAUTE, MD
    • Sub-Investigator: Mathilde LUCAS, MD
    • Sub-Investigator: Damien WAZ, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegetative State; 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.	Behavioral: Physiological recording in response to different types of stimuli; 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.; Behavioral: EEG recording in response to different types of stimuli; 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.
Experimental: Minimally Conscious State; 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.	Behavioral: Physiological recording in response to different types of stimuli; 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.; Behavioral: EEG recording in response to different types of stimuli; 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.
Experimental: Acquired Brain damaged patients without DOC; 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	Behavioral: Physiological recording in response to different types of stimuli; 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.; Behavioral: EEG recording in response to different types of stimuli; 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.
Experimental: Healthy subjects; 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.	Behavioral: Physiological recording in response to different types of stimuli; 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.; Behavioral: EEG recording in response to different types of stimuli; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
electrodermal response	skin conductance response measured with trans-cutaneus electrodes	at Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupillary response	use of eye-tracker	at Day 1
heart rate modification	use of transcutaneous electrode	at day 1
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.	at Day 2

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jacques LUAUTE, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Emotions; Electroencephalography; minimally conscious state; Awareness; electrodermal activity; Persistent Vegetative State
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Persistent Vegetative State
• Other Study ID Numbers: 69HCL18_0622; 2018-A02673-52 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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