Target Behaviours to Identify Minimally Conscious State Patients

Disorder of Consciousness Clinical Trial

Official title:

Target Behaviours to Identify Minimally Conscious State Patients by Using Coma Recovery Scale-Revised

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471753
• Other study ID #: 2020N39286
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: July 2020
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Minimally Conscious State
• Persistent Vegetative State

Intervention

Behavioral:
• Coma 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.

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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