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

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 .

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Key information

Conditions

Brain Diseases Brain Damage, Chronic Central Nervous System Diseases Coma Consciousness Disorders Disease Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness Vegetative State

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Diagnostic Test

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

Primary outcomes

Assess the reliability and validity of the Chinese version of the SECONDs

Time frame: 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

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Aug 11, 2022
Registry last updated: Aug 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed