Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Not Applicable

Completed

• Conditions: Patients in Minimally Conscious State
• Interventions: Behavioral: Personalized Objects; Behavioral: non-personalized Objects

• Registration Number: NCT02988206
• Lead Sponsor: Hangzhou Normal University

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.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2016-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Objects	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	non-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..
non-personalized objects	non-personalized Objects	The item "Functional Object Use" was assessed by using non-personalized objects

Primary Outcome Measures

Name	Time	Method
The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer	one week