Diagnostic Accuracy of the Vegetative and Minimally Conscious State

Disorder of Consciousness Clinical Trial

Official title:

Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139239
• Other study ID #: 2018N56745
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: October 22, 2019

Study information

• Verified date: November 2019
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 22, 2019
• Est. primary completion date: October 15, 2019
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Minimally Conscious State
• Persistent Vegetative State

Intervention

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

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (3)

Farquhar I, Fairclough JA. Sciatic block in lower limb surgery. Injury. 1990 Mar;21(2):107-9. — View Citation

Stender J, Gosseries O, Bruno MA, Charland-Verville V, Vanhaudenhuyse A, Demertzi A, Chatelle C, Thonnard M, Thibaut A, Heine L, Soddu A, Boly M, Schnakers C, Gjedde A, Laureys S. Diagnostic precision of PET imaging and functional MRI in disorders of consciousness: a clinical validation study. Lancet. 2014 Aug 9;384(9942):514-22. doi: 10.1016/S0140-6736(14)60042-8. Epub 2014 Apr 15. — View Citation

van Erp WS, Lavrijsen JC, Vos PE, Bor H, Laureys S, Koopmans RT. The vegetative state: prevalence, misdiagnosis, and treatment limitations. J Am Med Dir Assoc. 2015 Jan;16(1):85.e9-85.e14. doi: 10.1016/j.jamda.2014.10.014. Erratum in: J Am Med Dir Assoc. 2019 May;20(5):652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessed by the Coma Recovery Scale-Revised	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).	Within 10 days