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
About this trial
This is an interventional diagnostic trial for Patients in Minimally Conscious State
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.
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
NCT ID
NCT02988206
First Posted
December 5, 2016
Last Updated
December 12, 2016
Sponsor
Hangzhou Normal University
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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