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 .

Study Overview

• Status: Completed
• Conditions: Brain Diseases; Central Nervous System Diseases; Unconsciousness; Vegetative State
• Intervention / Treatment: Diagnostic test: Simplified Evaluation of CONsciousness Disorders (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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients in coma; Patients in coma were assessed by the SECONDs and CRS-R for five days.	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)
Experimental: Patients in unresponsive wakefulness syndrome; Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.	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)
Experimental: Patients in minimally conscious state; Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.	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)
Experimental: Patients in emerge from the minimally conscious state; Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hangzhou Normal University
• Investigators: Study Director: Haibo Di, International Vegetative State and Consciousness Science Institute,Hangzhou Normal University; Principal Investigator: Anqi Wang, International Vegetative State and Consciousness Science Institute,Hangzhou Normal University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; diagnosis; coma; disorder of consciousness; behavioral scale
• Additional Relevant MeSH Terms: Mental Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Damage, Chronic; Nervous System Diseases; Brain Diseases; Consciousness Disorders; Unconsciousness; Persistent Vegetative State; Central Nervous System Diseases
• Other Study ID Numbers: YCYY-20211021-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No