- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988206
Personalized Objects Can Improve the Diagnosis of EMCS From MCS
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Personalized Objects
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..
|
personalized objects are based on the observation or the reports from family
non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
|
Other: non-personalized objects
The item "Functional Object Use" was assessed by using non-personalized objects
|
non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer
Time Frame: one week
|
one week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016R423055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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