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

Not Applicable

Completed

• Conditions: Central Nervous System Diseases; Brain Diseases; Unconsciousness; Vegetative State
• Interventions: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

• Registration Number: NCT05496985
• Lead Sponsor: Hangzhou Normal University

Brief 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 .

Detailed 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

Study Timeline

• Study Start: 2021-12-20
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Status Verified: 2022-08
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients in coma	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients in coma were assessed by the SECONDs and CRS-R for five days.
Patients in unresponsive wakefulness syndrome	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.
Patients in emerge from the minimally conscious state	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days.
Patients in minimally conscious state	Simplified Evaluation of CONsciousness Disorders (SECONDs)	Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Primary Outcome Measures

Name	Time	Method
Assess the reliability and validity of the Chinese version of the SECONDs	Within 10 days	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
Diagnose the level of consciousness in patients through SECONDs and CRS-R	Within 10 days	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).
Diagnose the level of consciousness in patients through CRS-R	Within 10 days	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).

Trial Locations

Locations (1)

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