Personalized Objects Can Improve the Diagnosis of EMCS From MCS

Patients in Minimally Conscious State Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988206
• Other study ID #: 2016R423055
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 12, 2016
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Patients in Minimally Conscious State
• Persistent Vegetative State

Intervention

Behavioral:
• Personalized Objects
personalized objects are based on the observation or the reports from family
• non-personalized Objects
non-personalized objects are based on the suggestion in CRS-R,which are comb and cup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of behavioral response elicited by the stimuli suggested by CRS-R scale and the personalized stimuli they prefer		one week	Yes