Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

Brain Diseases Clinical Trial

Official title:

Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05496985
• Other study ID #: YCYY-20211021-003
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: August 2022
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

Description:

To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 14, 2022
• Est. primary completion date: March 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
• Age: 18-85 years old;
• No history of other neurological or psychiatric deficits;
• Ability to speak Chinese fluently;
• Medical stability (e.g., absence of mechanical ventilation, sedation, infection)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Consciousness Disorders
• Nervous System Diseases
• Persistent Vegetative State
• Unconsciousness
• Vegetative State

Intervention

Diagnostic Test:
• Simplified Evaluation of CONsciousness Disorders (SECONDs)
All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the reliability and validity of the Chinese version of the SECONDs	The reliability and validity of the Chinese version of the SECONDs were evaluated by calculating the weighted Cohen's Kappa and Spearman coefficients of the differences between SECONDs and CRS-R in the diagnosis of MCS and UWS patients	Within 10 days
Primary	Diagnose the level of consciousness in patients through SECONDs and CRS-R	Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Simplified Evaluation of CONsciousness Disorders (SECONDs).	Within 10 days
Primary	Diagnose the level of consciousness in patients through CRS-R	Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Coma Recovery Scale-Revised (CRS-R).	Within 10 days