<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/NCT02988206</url>
  </required_header>
  <id_info>
    <org_study_id>2016R423055</org_study_id>
    <nct_id>NCT02988206</nct_id>
  </id_info>
  <brief_title>Personalized Objects Can Improve the Diagnosis of EMCS From MCS</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangzhou Normal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hangzhou Normal University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study，researchers will use personalized objects to assess patients' level of&#xD;
      consciousness in chronic patients in minimally conscious state (MCS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors&#xD;
      in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own&#xD;
      name and face, are more effective to elicit the patient's response than that of&#xD;
      non-self-referential stimuli.&#xD;
&#xD;
      The item &quot;Functional Object Use&quot; was assessed by using personalized objects (e.g., cigarette,&#xD;
      paper) and non-personalized objects, which presented in a random order.The rest assessments&#xD;
      were performed following the standard protocol of CRS-R. The differences between functional&#xD;
      use of the two types of objects was analyzed by Chi-square test.&#xD;
&#xD;
      Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the&#xD;
      using of personalized objects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Patients in Minimally Conscious State</condition>
  <arm_group>
    <arm_group_label>Personalized Objects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The item &quot;Functional Object Use&quot; was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-personalized objects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The item &quot;Functional Object Use&quot; was assessed by using non-personalized objects</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalized Objects</intervention_name>
    <description>personalized objects are based on the observation or the reports from family</description>
    <arm_group_label>Personalized Objects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>non-personalized Objects</intervention_name>
    <description>non-personalized objects are based on the suggestion in CRS-R,which are comb and cup</description>
    <arm_group_label>Personalized Objects</arm_group_label>
    <arm_group_label>non-personalized objects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients in minimally conscious state;&#xD;
&#xD;
          -  patients with stable condition;&#xD;
&#xD;
          -  each patient has athletic ability to some extent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  premorbid neurology antecedent;&#xD;
&#xD;
          -  patients in coma or vegetative state;&#xD;
&#xD;
          -  patients &lt; 1 months after the acute brain injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hangzhou Normal University</investigator_affiliation>
    <investigator_full_name>Yuxiao Sun</investigator_full_name>
    <investigator_title>Undergraduate student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Persistent Vegetative State</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/NCT02988206
org study id: 2016R423055
nct id: NCT02988206
lead sponsor: 
has dmc: Yes
In this study，researchers will use personalized objects to assess patients' level of
      consciousness in chronic patients in minimally conscious state (MCS).
The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors
      in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own
      name and face, are more effective to elicit the patient's response than that of
      non-self-referential stimuli.

      The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette,
      paper) and non-personalized objects, which presented in a random order.The rest assessments
      were performed following the standard protocol of CRS-R. The differences between functional
      use of the two types of objects was analyzed by Chi-square test.

      Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the
      using of personalized objects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
time frame: one week
arm group label: Personalized Objects
arm group type: Other
description: The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order..
arm group label: non-personalized objects
arm group type: Other
description: The item "Functional Object Use" was assessed by using non-personalized objects
intervention type: Behavioral
intervention name: Personalized Objects
description: personalized objects are based on the observation or the reports from family
arm group label: Personalized Objects
intervention type: Behavioral
intervention name: non-personalized Objects
description: non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
arm group label: Personalized Objects
arm group label: non-personalized objects
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hangzhou Normal University
investigator full name: Yuxiao Sun
investigator title: Undergraduate student
mesh term: Persistent Vegetative State
sharing ipd: No