<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/NCT04411719</url>
  </required_header>
  <id_info>
    <org_study_id>Outcome in DOC</org_study_id>
    <nct_id>NCT04411719</nct_id>
  </id_info>
  <brief_title>Outcome Prediction in Patients With Acute Disorders of Consciousness</brief_title>
  <official_title>Prognosis of Acute DOC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prior research has indicated a link between outcomes in patients with disorders of&#xD;
      consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree&#xD;
      of uncertainty in acute situations, this study plans to record EEG responses and observe&#xD;
      microexpressions in DOC patients during exposure to auditory stimuli, with the aim to&#xD;
      identify more reliable prognostic indicators. The goal is to uncover potential patterns or&#xD;
      signals that can contribute to a more comprehensive understanding of a patient's condition,&#xD;
      and thereby provide more accurate prognostication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study intends to probe the potential of electroencephalography (EEG) and microexpression&#xD;
      analysis for predicting the outcomes of acutely unresponsive patients within the intensive&#xD;
      care unit (ICU). Previous research has illuminated a relationship between patients' emotional&#xD;
      responses to auditory stimuli and their prognosis. However, the predictive utility of these&#xD;
      responses in the context of acute conditions remains largely unexplored.&#xD;
&#xD;
      At the onset of the study, participants will undergo EEG monitoring while exposed to a&#xD;
      pre-determined set of emotional auditory stimuli. Additionally, the patients' facial&#xD;
      expressions will be captured via video for subsequent microexpression analysis.&#xD;
&#xD;
      Follow-up assessments of the patients' status will be conducted at three, six, and&#xD;
      twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these&#xD;
      EEG and microexpression responses. This study aims to identify possible correlations between&#xD;
      these findings, the patients' diagnoses, and their respective outcomes over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2022</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glasgow Outcome Scale-Extended (GOS-E)</measure>
    <time_frame>Month 1</time_frame>
    <description>GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing such an injury. It has eight categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glasgow Outcome Scale-Extended (GOS-E)</measure>
    <time_frame>Month 3</time_frame>
    <description>GOSE will be assessed 3 months after brain injury.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glasgow Outcome Scale-Extended (GOS-E)</measure>
    <time_frame>Month 6</time_frame>
    <description>GOSE will be assessed 6 months after brain injury.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glasgow Outcome Scale-Extended (GOS-E)</measure>
    <time_frame>Month 12</time_frame>
    <description>GOSE will be assessed 12 months after brain injury.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Consciousness Disorder</condition>
  <arm_group>
    <arm_group_label>EEG and Microexpression Analysis</arm_group_label>
    <description>Participants will be acutely unresponsive ICU patients. They will undergo non-invasive observational procedures, including EEG monitoring during exposure to emotional auditory stimuli, and concurrent video recording for microexpression analysis. Patient outcomes will be assessed at three, six, and twelve-month intervals post-initial observation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Unresponsive patients after severe brain injury.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute brain injury (&lt;28 days) in ICU&#xD;
&#xD;
          -  GCS ≤ 8&#xD;
&#xD;
          -  ≥ 2 days after sedation&#xD;
&#xD;
          -  Normal hearing, with auditory startle reflex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Children under 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benyan Luo, Prof, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benyan Luo, Prof</last_name>
    <phone>0571-87236537</phone>
    <email>luobenyan@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benyan Luo, Prof</last_name>
      <email>luobenyan@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04411719
org study id: Outcome in DOC
nct id: NCT04411719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Prior research has indicated a link between outcomes in patients with disorders of
      consciousness (DOC) and their responses to emotional auditory stimuli. Given the high degree
      of uncertainty in acute situations, this study plans to record EEG responses and observe
      microexpressions in DOC patients during exposure to auditory stimuli, with the aim to
      identify more reliable prognostic indicators. The goal is to uncover potential patterns or
      signals that can contribute to a more comprehensive understanding of a patient's condition,
      and thereby provide more accurate prognostication.
This study intends to probe the potential of electroencephalography (EEG) and microexpression
      analysis for predicting the outcomes of acutely unresponsive patients within the intensive
      care unit (ICU). Previous research has illuminated a relationship between patients' emotional
      responses to auditory stimuli and their prognosis. However, the predictive utility of these
      responses in the context of acute conditions remains largely unexplored.

      At the onset of the study, participants will undergo EEG monitoring while exposed to a
      pre-determined set of emotional auditory stimuli. Additionally, the patients' facial
      expressions will be captured via video for subsequent microexpression analysis.

      Follow-up assessments of the patients' status will be conducted at three, six, and
      twelve-month intervals. Using cutting-edge analytical techniques, the goal is to decode these
      EEG and microexpression responses. This study aims to identify possible correlations between
      these findings, the patients' diagnoses, and their respective outcomes over time.
observational model: Cohort
time perspective: Prospective
measure: Glasgow Outcome Scale-Extended (GOS-E)
time frame: Month 1
description: GOS-E is an extended version of the Glasgow Outcome Scale (GOS), which was developed to provide a more detailed assessment of patient functionality and quality of life after experiencing such an injury. It has eight categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery.
measure: Glasgow Outcome Scale-Extended (GOS-E)
time frame: Month 3
description: GOSE will be assessed 3 months after brain injury.
measure: Glasgow Outcome Scale-Extended (GOS-E)
time frame: Month 6
description: GOSE will be assessed 6 months after brain injury.
measure: Glasgow Outcome Scale-Extended (GOS-E)
time frame: Month 12
description: GOSE will be assessed 12 months after brain injury.
arm group label: EEG and Microexpression Analysis
description: Participants will be acutely unresponsive ICU patients. They will undergo non-invasive observational procedures, including EEG monitoring during exposure to emotional auditory stimuli, and concurrent video recording for microexpression analysis. Patient outcomes will be assessed at three, six, and twelve-month intervals post-initial observation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Benyan Luo, Prof, Dr
role: Principal Investigator
affiliation: Zhejiang University
last name: Benyan Luo, Prof
phone: 0571-87236537
email: luobenyan@zju.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Consciousness Disorders
sharing ipd: No