Clinical trial NCT05496985: Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
Official title: Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Diseases
Vegetative State
Unconsciousness
Central Nervous System Diseases
Keywords: coma
disorder of consciousness
behavioral scale
rehabilitation
diagnosis
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis \[17\], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Assess the reliability and validity of the Chinese version of the SECONDs
timeFrame: Within 10 days
measure: Diagnose the level of consciousness in patients through SECONDs and CRS-R
timeFrame: Within 10 days
measure: Diagnose the level of consciousness in patients through CRS-R
timeFrame: Within 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
name: Haibo Di
role: STUDY_DIRECTOR
affiliation: International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
name: Anqi Wang
role: PRINCIPAL_INVESTIGATOR
References: