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Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Primary Purpose

Patients in Minimally Conscious State

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized Objects
non-personalized Objects
Sponsored by
Hangzhou Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients in Minimally Conscious State

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients in minimally conscious state;
  • patients with stable condition;
  • each patient has athletic ability to some extent.

Exclusion Criteria:

  • premorbid neurology antecedent;
  • patients in coma or vegetative state;
  • patients < 1 months after the acute brain injury.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Personalized Objects

    non-personalized objects

    Arm 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..

    The item "Functional Object Use" was assessed by using non-personalized objects

    Outcomes

    Primary Outcome Measures

    The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2016
    Last Updated
    December 12, 2016
    Sponsor
    Hangzhou Normal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02988206
    Brief Title
    Personalized Objects Can Improve the Diagnosis of EMCS From MCS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hangzhou Normal University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In this study,researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patients in Minimally Conscious State

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalized Objects
    Arm Type
    Other
    Arm 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 Title
    non-personalized objects
    Arm Type
    Other
    Arm Description
    The item "Functional Object Use" was assessed by using non-personalized objects
    Intervention Type
    Behavioral
    Intervention Name(s)
    Personalized Objects
    Intervention Description
    personalized objects are based on the observation or the reports from family
    Intervention Type
    Behavioral
    Intervention Name(s)
    non-personalized Objects
    Intervention Description
    non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
    Primary Outcome Measure Information:
    Title
    The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients in minimally conscious state; patients with stable condition; each patient has athletic ability to some extent. Exclusion Criteria: premorbid neurology antecedent; patients in coma or vegetative state; patients < 1 months after the acute brain injury.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29649978
    Citation
    Sun Y, Wang J, Heine L, Huang W, Wang J, Hu N, Hu X, Fang X, Huang S, Laureys S, Di H. Personalized objects can optimize the diagnosis of EMCS in the assessment of functional object use in the CRS-R: a double blind, randomized clinical trial. BMC Neurol. 2018 Apr 12;18(1):38. doi: 10.1186/s12883-018-1040-5.
    Results Reference
    derived

    Learn more about this trial

    Personalized Objects Can Improve the Diagnosis of EMCS From MCS

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