Diagnostic Accuracy of the Vegetative and Minimally Conscious State

Sponsor
Hangzhou Normal University (Other)
Overall Status
Completed
CT.gov ID
NCT04139239
Collaborator
(none)
150
1
27.7
5.4

Study Details

Study Description

Brief Summary

The aim of this study was to investigate diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Coma Recovery Scale-revision

Detailed Description

In this study, DOC patients with clinical consensus of DOC were enrolled. The investigators used Coma Recovery Scale-revision (CRS-R) to assess consciousness levels for all DOC patients during ten days.

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Oct 22, 2019

Arms and Interventions

Arm Intervention/Treatment
Patients with disorders of consciousness

Diagnostic Test: Coma Recovery Scale-revision
Patients were assessed by Coma Recovery Scale-revision to detect the DOC patients enrolled by clinicians.

Outcome Measures

Primary Outcome Measures

  1. Assessed by the Coma Recovery Scale-Revised [Within 10 days]

    All patients were assessed by the Coma Recovery Scale-Revised within 10 days to detect the consciousness level. CRS-R consists of six sub-scales with 23 items, which evaluate the patients' auditory, visual, motor, Oromotor/Verbal, communication and arousal functions. For each subscale, the lower score reflected reflexivity related to the brain stem, while the higher score reflected non-reflexivity related to higher cortical functions (0-23).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All

Inclusion

  1. at least 18 years old;

  2. acquired brain injury;

  3. no neuromuscular blockers or sedatives were used within 48 hours of enrollment.

Exclusion Criteria:
  1. there are functional disorders caused by progressive mental diseases;

  2. persistent seizures;

  3. unstable vital signs;

  4. double upper limb frustration, fracture.

Contacts and Locations

Locations

Site City State Country Postal Code
1 International Vegetative State and Consciousness Science Institute, Hangzhou Normal University Hangzhou Zhejiang China 3100036

Sponsors and Collaborators

  • Hangzhou Normal University

Investigators

  • Study Chair: Haibo Di, Pro., Hangzhou Normal University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jing Wang, Principal Investigator, Hangzhou Normal University
ClinicalTrials.gov Identifier:
NCT04139239
Other Study ID Numbers:
  • 2018N56745
First Posted:
Oct 25, 2019
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jing Wang, Principal Investigator, Hangzhou Normal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2019