Target Behaviours to Identify Minimally Conscious State Patients

NCT04471753 | Completed

• 1 other identifier: 2020N39286
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder of Consciousness; Minimally Conscious State

Keywords

disorders of consciousness; Coma Recovery Scale-revision; minimally conscious state

Outcome Measures

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.

  Within 7 days

Study Arms (1)

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

Coma Recovery Scale-Revised BEHAVIORAL

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.

Patients with disorders of consciousness

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (2)

• 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.

  PMID: 28543735 BACKGROUND

• 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.

  PMID: 21112421 RESULT

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Study Officials

• Haibo Di, Pro.

  Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 15, 2020
• Study Start: August 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

CN (1)