<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03023657</url>
  </required_header>
  <id_info>
    <org_study_id>1608177</org_study_id>
    <secondary_id>2016-A01973-48</secondary_id>
    <nct_id>NCT03023657</nct_id>
  </id_info>
  <brief_title>Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient</brief_title>
  <acronym>DAME</acronym>
  <official_title>Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Severe brain injuries lead to disorders of consciousness after coma. During this awakening&#xD;
      period, detection of arousal is critical to the adaptation of medical strategy, but global&#xD;
      paralysis, including facial expression, make the clinical assessment very difficult.&#xD;
      Emotional facial expressions are a significant part of this clinical assessment. They are&#xD;
      both a landmark of the internal state of the patient (comfort versus discomfort) and a&#xD;
      landmark of the relational level with his environment. Visible emotional facial expression is&#xD;
      a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely&#xD;
      noticeable and very brief. These micro expressions are usually produced when one tried to&#xD;
      voluntary hide emotional expressions. In this study, we hypothesize that some patients&#xD;
      awakening from coma could still produce microexpression before being able to produce visible&#xD;
      emotional facial expressions. This ability to produce micro-expression could be an early&#xD;
      landmark of relational awakening in severe brain lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    difficulties to realize the protocol&#xD;
  </why_stopped>
  <start_date type="Actual">June 23, 2017</start_date>
  <completion_date type="Actual">October 16, 2017</completion_date>
  <primary_completion_date type="Actual">October 16, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>facial micro expression found in at least one patient on one video recording</measure>
    <time_frame>Every day for a week then once a week for four weeks</time_frame>
    <description>Optical camera and thermal camera</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Consciousness Disorder</condition>
  <arm_group>
    <arm_group_label>Severe brain-damaged patient in coma awakening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For each patient, video sessions of the face will be performed during a waking period, until the spontaneous macro-EFE (Emotional Facial Expression) reappears. The video sessions will be done without stimulation or with visual, auditory or tactile stimulation. The sessions will be daily for 7 days then weekly for a maximum duration of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Detection of arousal</intervention_name>
    <description>Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury</description>
    <arm_group_label>Severe brain-damaged patient in coma awakening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Brain-damaged patient (stroke, traumatic brain injury, anoxia)&#xD;
&#xD;
          -  Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation&#xD;
&#xD;
          -  Patient without spontaneous or stimulated facial expressions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal GIRAUX, MDPhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Saint-Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arousal</keyword>
  <keyword>Consciousness Disorders</keyword>
  <keyword>vegetative state</keyword>
  <keyword>minimally conscious state</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Consciousness Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03023657
org study id: 1608177
secondary id: 2016-A01973-48
nct id: NCT03023657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe brain injuries lead to disorders of consciousness after coma. During this awakening
      period, detection of arousal is critical to the adaptation of medical strategy, but global
      paralysis, including facial expression, make the clinical assessment very difficult.
      Emotional facial expressions are a significant part of this clinical assessment. They are
      both a landmark of the internal state of the patient (comfort versus discomfort) and a
      landmark of the relational level with his environment. Visible emotional facial expression is
      a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely
      noticeable and very brief. These micro expressions are usually produced when one tried to
      voluntary hide emotional expressions. In this study, we hypothesize that some patients
      awakening from coma could still produce microexpression before being able to produce visible
      emotional facial expressions. This ability to produce micro-expression could be an early
      landmark of relational awakening in severe brain lesions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: facial micro expression found in at least one patient on one video recording
time frame: Every day for a week then once a week for four weeks
description: Optical camera and thermal camera
arm group label: Severe brain-damaged patient in coma awakening
arm group type: Experimental
description: For each patient, video sessions of the face will be performed during a waking period, until the spontaneous macro-EFE (Emotional Facial Expression) reappears. The video sessions will be done without stimulation or with visual, auditory or tactile stimulation. The sessions will be daily for 7 days then weekly for a maximum duration of 4 weeks.
intervention type: Other
intervention name: Detection of arousal
description: Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury
arm group label: Severe brain-damaged patient in coma awakening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Pascal GIRAUX, MDPhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Consciousness Disorders
sharing ipd: No