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CompletedNCT04471753Updated Jul 15, 2020

Target Behaviours to Identify Minimally Conscious State Patients

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 84 Years. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Hangzhou Normal University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
215
Ages
18 Years to 84 Years
Sex
All
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Study summary

To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery Scale-Revised assessment of minimally conscious state diagnosis and evidence for the simplification of Coma Recovery Scale-Revised in the future.

Read the detailed description

Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome patients were distinguished.

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Conditions studied

  • Disorder of Consciousness
  • Minimally Conscious State

Keywords

  • disorders of consciousness
  • Coma Recovery Scale-revision
  • minimally conscious state
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In context

Consciousness Disorders

290 studies on the registry are indexed under Consciousness Disorders; 109 are open to participants now.

This study's enrollment of 215 is above the median of 79 across 95 observational studies indexed under Consciousness Disorders.

Browse Consciousness Disorders studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients were assessed by the Coma Recovery Scale-Revised for several times with seven days.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.

Exclusion criteria

Exclusion Criteria:

  • Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment were excluded.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
215 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with disorders of consciousness

    Patients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.

    Behavioral: Coma Recovery Scale-Revised

Interventions

  • BehavioralComa Recovery Scale-Revised

    Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished.

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What researchers measure

Primary outcomes

  1. Coma Recovery Scale-Revised

    The Coma Recovery Scale-Revised has 23 items, which evaluate the patients' auditory, visual, motor, oromotor/verbal, communication, and arousal functions. For each subscale, the lower score reflects reflexivity related to the brain stem, while the higher score reflects non-reflexivity related to higher cortical functions.

    Time frame: Within 7 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

  • Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962. PubMed 28543735 ↗
  • American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218. PubMed 21112421 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04471753
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Principal Investigator, Hangzhou Normal University) — Principal investigator
First posted
Jul 15, 2020
Start date
Aug 1, 2017
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
Jul 15, 2020

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 ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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