Personalized Objects Can Improve the Diagnosis of EMCS From MCS

NCT ID: NCT02988206

Last Updated: 2016-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Patients in Minimally Conscious State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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..

Group Type OTHER

Personalized Objects

Intervention Type BEHAVIORAL

personalized objects are based on the observation or the reports from family

non-personalized Objects

Intervention Type BEHAVIORAL

non-personalized objects are based on the suggestion in CRS-R,which are comb and cup

non-personalized objects

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

Group Type OTHER

non-personalized Objects

Intervention Type BEHAVIORAL

non-personalized objects are based on the suggestion in CRS-R,which are comb and cup

Interventions

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Personalized Objects

personalized objects are based on the observation or the reports from family

Intervention Type BEHAVIORAL

non-personalized Objects

non-personalized objects are based on the suggestion in CRS-R,which are comb and cup

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Normal University

OTHER

Sponsor Role lead

Responsible Party

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Yuxiao Sun

Undergraduate student

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 29649978 (View on PubMed)

Other Identifiers

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2016R423055

Identifier Type: -

Identifier Source: org_study_id