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Completed

NCT Number: NCT04139239

Diagnostic Accuracy of the Vegetative and Minimally Conscious State

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

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Key information

Conditions

Disorder of Consciousness Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion

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

Exclusion criteria

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

Treatment and study plan

Coma Recovery Scale-revision

Diagnostic Test

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

Primary outcomes

  1. Assessed by the Coma Recovery Scale-Revised

    Time frame: Within 10 days

    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).

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2019
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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