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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02673-52 | Other Identifier | ID-RCB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegetative State | Experimental | 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. |
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| Minimally Conscious State | Experimental | 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. |
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| Acquired Brain damaged patients without DOC | Experimental | 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 |
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| Healthy subjects | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiological recording in response to different types of stimuli | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| electrodermal response | skin conductance response measured with trans-cutaneus electrodes | at Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| pupillary response | use of eye-tracker | at Day 1 |
| heart rate modification | use of transcutaneous electrode | at day 1 |
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Inclusion Criteria:
For Patients :
For Healthy participants:
Exclusion Criteria:
For Patients :
For Healthy participants:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques LUAUTE, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | 69500 | France |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 22, 2026 |
| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| EEG recording in response to different types of stimuli | Behavioral | 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. |
|
| 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 |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |