Target Behaviours to Identify Minimally Conscious State Patients

Completed

• Conditions: Minimally Conscious State; Disorder of Consciousness
• Interventions: Behavioral: Coma Recovery Scale-Revised

• Registration Number: NCT04471753
• Lead Sponsor: Hangzhou Normal University

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.

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Last Update Submitted: 2020-07-12
• Study First Posted: 2020-07-15
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with disorders of consciousness	Coma Recovery Scale-Revised	Patients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.

Primary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised	Within 7 days	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.

Trial Locations

Locations (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China