Diagnostic Accuracy of the Vegetative and Minimally Conscious State

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

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

Study Overview

• Status: Completed
• Conditions: Disorder of Consciousness; Minimally Conscious State
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 3100036
      • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with DOC chosen by clinician were included in the study at Department of Neurology and Rehabilitation center of hospital. All patients were diagnosed by the Coma Recovery Scale-revision (CRS-R) for five times at least within 10 days.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Farquhar I, Fairclough JA. Sciatic block in lower limb surgery. Injury. 1990 Mar;21(2):107-9. doi: 10.1016/0020-1383(90)90066-4.
• 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.
• 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.
• Wang J, Hu X, Hu Z, Sun Z, Laureys S, Di H. The misdiagnosis of prolonged disorders of consciousness by a clinical consensus compared with repeated coma-recovery scale-revised assessment. BMC Neurol. 2020 Sep 12;20(1):343. doi: 10.1186/s12883-020-01924-9.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Disorders of consciousness; Coma Recovery Scale-revision; Diagnostic accuracy
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Persistent Vegetative State
• Other Study ID Numbers: 2018N56745

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No