NCT04139239

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

October 23, 2019

Last Update Submit

November 13, 2019

Conditions

Disorder of ConsciousnessMinimally Conscious State

Keywords

Disorders of consciousnessComa Recovery Scale-revisionDiagnostic accuracy

Outcome Measures

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).

    Within 10 days

Study Arms (1)

Patients with disorders of consciousness

Diagnostic Test: Coma Recovery Scale-revision

Interventions

Coma Recovery Scale-revisionDIAGNOSTIC_TEST

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

Patients with disorders of consciousness

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • at least 18 years old;
  • acquired brain injury;
  • no neuromuscular blockers or sedatives were used within 48 hours of enrollment.

You may not qualify if:

  • there are functional disorders caused by progressive mental diseases;
  • persistent seizures;
  • unstable vital signs;
  • double upper limb frustration, fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (4)

  • 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.

    PMID: 2351462BACKGROUND

  • 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.

    PMID: 25528282BACKGROUND

  • 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.

    PMID: 24746174BACKGROUND

  • 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.

    PMID: 32919461DERIVED

MeSH Terms

Conditions

Consciousness DisordersPersistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesUnconsciousness

Study Officials

  • Haibo Di, Pro.

    Hangzhou Normal University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2019

First Posted

October 25, 2019

Study Start

July 1, 2017

Primary Completion

October 15, 2019

Study Completion

October 22, 2019

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations

CN(1)