Diagnostic Accuracy of the Vegetative and Minimally Conscious State

NCT ID: NCT04139239

Last Updated: 2019-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-10-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Disorder of Consciousness Minimally Conscious State

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with disorders of consciousness

Coma Recovery Scale-revision

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Coma Recovery Scale-revision

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

1. there are functional disorders caused by progressive mental diseases;
2. persistent seizures;
3. unstable vital signs;
4. double upper limb frustration, fracture.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hangzhou Normal University

OTHER

Sponsor Role lead

Responsible Party

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Jing Wang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haibo Di, Pro.

Role: STUDY_CHAIR

Hangzhou Normal University

Locations

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International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 2351462 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25528282 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24746174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32919461 (View on PubMed)

Other Identifiers

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2018N56745

Identifier Type: -

Identifier Source: org_study_id

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