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Emotion Assessment to Study Consciousness in Awakening Patients (EmotiCones)

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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

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
electrodermal response [ Time Frame: at Day 1 ]
skin conductance response measured with trans-cutaneus electrodes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • pupillary response [ Time Frame: at Day 1 ]
    use of eye-tracker
  • heart rate modification [ Time Frame: at day 1 ]
    use of transcutaneous electrode
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotion Assessment to Study Consciousness in Awakening Patients
Official Title  ICMJE Emotion Assessment to Study Consciousness in Awakening Patients
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Persistent Vegetative State
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Physiological recording in response to different types of stimuli
    • Behavioral: EEG recording in response to different types of stimuli
  • 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.
    Interventions:
    • Behavioral: Physiological recording in response to different types of stimuli
    • Behavioral: EEG recording in response to different types of stimuli
  • 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
    Interventions:
    • Behavioral: Physiological recording in response to different types of stimuli
    • Behavioral: EEG recording in response to different types of stimuli
  • 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.
    Interventions:
    • Behavioral: Physiological recording in response to different types of stimuli
    • Behavioral: EEG recording in response to different types of stimuli
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jacques LUAUTE, MD 478865023 ext +33 jacques.luaute@chu-lyon.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706170
Other Study ID Numbers  ICMJE 69HCL18_0622
2018-A02673-52 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques LUAUTE, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP