An interventional study of Physiological recording in response to different types of stimuli and EEG recording in response to different types of stimuli in Persistent Vegetative State, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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).
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 15 is below the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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For Patients :
For Healthy participants:
Exclusion Criteria:
For Patients :
For Healthy participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: EEG recording in response to different types of stimuli
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 · Behavioral: EEG recording in response to different types of stimuli
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 · Behavioral: EEG recording in response to different types of stimuli
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 · 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.
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.
electrodermal response
skin conductance response measured with trans-cutaneus electrodes
Time frame: at Day 1
pupillary response
use of eye-tracker
Time frame: at Day 1
heart rate modification
use of transcutaneous electrode
Time frame: 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.
Time frame: at Day 2
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Sep 2021, 31 months.
Of 23 interventional studies with no phase under Persistent Vegetative State, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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