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Emotion Assessment to Study Consciousness in Awakening Patients (EmotiCones)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706170
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Persistent Vegetative State Behavioral: Physiological recording in response to different types of stimuli Behavioral: EEG recording in response to different types of stimuli Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Emotion Assessment to Study Consciousness in Awakening Patients
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

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.




Primary Outcome Measures :
  1. electrodermal response [ Time Frame: at Day 1 ]
    skin conductance response measured with trans-cutaneus electrodes


Secondary Outcome Measures :
  1. pupillary response [ Time Frame: at Day 1 ]
    use of eye-tracker

  2. heart rate modification [ Time Frame: at day 1 ]
    use of transcutaneous electrode

  3. Variation of the intensity of different Event Related Potentials [ Time Frame: at Day 2 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706170


Contacts
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Contact: Jacques LUAUTE, MD 478865023 ext +33 jacques.luaute@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Jacques LUAUTE, MD    478865023 ext +33    jacques.luaute@chu-lyon.fr   
Principal Investigator: Jacques LUAUTE, MD         
Sub-Investigator: Mathilde LUCAS, MD         
Sub-Investigator: Damien WAZ, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jacques LUAUTE, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03706170    
Other Study ID Numbers: 69HCL18_0622
2018-A02673-52 ( Other Identifier: ID-RCB )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Persistent Vegetative State
minimally conscious state
Emotions
Awareness
electrodermal activity
Electroencephalography
Additional relevant MeSH terms:
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Persistent Vegetative State
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations