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CompletedNCT04139239Updated Nov 14, 2019

Diagnostic Accuracy of the Vegetative and Minimally Conscious State

An observational study in Disorder of Consciousness and Minimally Conscious State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-11-14.

Sponsored by Hangzhou Normal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Disorder of Consciousness
  • Minimally Conscious State

Keywords

  • Disorders of consciousness
  • Coma Recovery Scale-revision
  • Diagnostic accuracy
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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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.

Inclusion criteria

  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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with disorders of consciousness

    Diagnostic Test: Coma Recovery Scale-revision

Interventions

  • Diagnostic testComa Recovery Scale-revision

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

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Within 10 days

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Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
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References and documents

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. PubMed 2351462 ↗
  • 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. doi: 10.1016/j.jamda.2019.01.145. PubMed 25528282 ↗
  • 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. PubMed 24746174 ↗
  • 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. PubMed 32919461 ↗
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Registry details

Key details

Study ID
NCT04139239
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Principal Investigator, Hangzhou Normal University) — Principal investigator
First posted
Oct 25, 2019
Start date
Jul 1, 2017
Primary completion
Oct 15, 2019
Completion
Oct 22, 2019
Last update
Nov 14, 2019

Study contacts

Haibo Di, Pro.
study chair · Hangzhou Normal University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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