Emotion Assessment to Study Consciousness in Awakening Patients

Study Overview
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Brief Summary
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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).

Official Title
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Emotion Assessment to Study Consciousness in Awakening Patients

Conditions
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Persistent Vegetative State

Intervention / Treatment
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* Behavioral: Physiological recording in response to different types of stimuli
* Behavioral: EEG recording in response to different types of stimuli


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vegetative State<br>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<br>* 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.<br>Behavioral: EEG recording in response to different types of stimuli<br>* 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.<br>|
| Experimental: Minimally Conscious State<br>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<br>* 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.<br>Behavioral: EEG recording in response to different types of stimuli<br>* 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.<br>|
| Experimental: Acquired Brain damaged patients without DOC<br>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<br>* 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.<br>Behavioral: EEG recording in response to different types of stimuli<br>* 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.<br>|
| Experimental: Healthy subjects<br>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<br>* 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.<br>Behavioral: EEG recording in response to different types of stimuli<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent Vegetative State, minimally conscious state, Emotions, Awareness, electrodermal activity, Electroencephalography