<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/NCT04471753</url>
  </required_header>
  <id_info>
    <org_study_id>2020N39286</org_study_id>
    <nct_id>NCT04471753</nct_id>
  </id_info>
  <brief_title>Target Behaviours to Identify Minimally Conscious State Patients</brief_title>
  <official_title>Target Behaviours to Identify Minimally Conscious State Patients by Using Coma Recovery Scale-Revised</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangzhou Normal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hangzhou Normal University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyse the frequency of the consciousness behaviour response for patients with minimally&#xD;
      conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for&#xD;
      obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery&#xD;
      Scale-Revised assessment of minimally conscious state diagnosis and evidence for the&#xD;
      simplification of Coma Recovery Scale-Revised in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum&#xD;
      of the highest score on the evaluated subscales was taken as the final score, and the final&#xD;
      diagnosis of patients was obtained (the highest score of each subscale was recorded). All&#xD;
      participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7&#xD;
      days. According to the results of the Coma Recovery Scale-Revised assessment, minimally&#xD;
      conscious state and unresponsive wakefulness syndrome patients were distinguished.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>Coma Recovery Scale-Revised</measure>
    <time_frame>Within 7 days</time_frame>
    <description>The Coma Recovery Scale-Revised has 23 items, which evaluate the patients' auditory, visual, motor, oromotor/verbal, communication, and arousal functions. For each subscale, the lower score reflects reflexivity related to the brain stem, while the higher score reflects non-reflexivity related to higher cortical functions.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">215</enrollment>
  <condition>Disorder of Consciousness</condition>
  <condition>Minimally Conscious State</condition>
  <arm_group>
    <arm_group_label>Patients with disorders of consciousness</arm_group_label>
    <description>Patients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coma Recovery Scale-Revised</intervention_name>
    <description>Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished.</description>
    <arm_group_label>Patients with disorders of consciousness</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients were assessed by the Coma Recovery Scale-Revised for several times with seven&#xD;
        days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days)&#xD;
             were included in neurosurgery, neurology, and neurorehabilitation units.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment&#xD;
             were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Haibo Di, Pro.</last_name>
    <role>Study Chair</role>
    <affiliation>Hangzhou Normal University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Vegetative State and Consciousness Science Institute, Hangzhou Normal University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>3100036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.</citation>
    <PMID>28543735</PMID>
  </reference>
  <results_reference>
    <citation>American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.</citation>
    <PMID>21112421</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 12, 2020</last_update_submitted>
  <last_update_submitted_qc>July 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hangzhou Normal University</investigator_affiliation>
    <investigator_full_name>Jing Wang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>disorders of consciousness</keyword>
  <keyword>Coma Recovery Scale-revision</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>
    <mesh_term>Persistent Vegetative State</mesh_term>
  </condition_browse>
  <!-- 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/NCT04471753
org study id: 2020N39286
nct id: NCT04471753
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To analyse the frequency of the consciousness behaviour response for patients with minimally
      conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for
      obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery
      Scale-Revised assessment of minimally conscious state diagnosis and evidence for the
      simplification of Coma Recovery Scale-Revised in the future.
Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum
      of the highest score on the evaluated subscales was taken as the final score, and the final
      diagnosis of patients was obtained (the highest score of each subscale was recorded). All
      participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7
      days. According to the results of the Coma Recovery Scale-Revised assessment, minimally
      conscious state and unresponsive wakefulness syndrome patients were distinguished.
observational model: Cohort
time perspective: Prospective
measure: Coma Recovery Scale-Revised
time frame: Within 7 days
description: The Coma Recovery Scale-Revised has 23 items, which evaluate the patients' auditory, visual, motor, oromotor/verbal, communication, and arousal functions. For each subscale, the lower score reflects reflexivity related to the brain stem, while the higher score reflects non-reflexivity related to higher cortical functions.
arm group label: Patients with disorders of consciousness
description: Patients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.
intervention type: Behavioral
intervention name: Coma Recovery Scale-Revised
description: Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished.
arm group label: Patients with disorders of consciousness
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
last name: Haibo Di, Pro.
role: Study Chair
affiliation: Hangzhou Normal University
facility: 
country: China
citation: Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.
PMID: 28543735
citation: American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.
PMID: 21112421
responsible party type: Principal Investigator
investigator affiliation: Hangzhou Normal University
investigator full name: Jing Wang
investigator title: Principal Investigator
mesh term: Consciousness Disorders
mesh term: Persistent Vegetative State