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

NCT05496985 | Completed

• 1 other identifier: YCYY-20211021-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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 .

Conditions

Brain Diseases; Vegetative State; Unconsciousness; Central Nervous System Diseases

Keywords

coma; disorder of consciousness; behavioral scale; rehabilitation; diagnosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Patients in coma

EXPERIMENTAL

Patients in coma were assessed by the SECONDs and CRS-R for five days.

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in unresponsive wakefulness syndrome

EXPERIMENTAL

Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in minimally conscious state

EXPERIMENTAL

Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days.

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients in emerge from the minimally conscious state

EXPERIMENTAL

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)

Interventions

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)

Patients in coma; Patients in emerge from the minimally conscious state; Patients in minimally conscious state; Patients in unresponsive wakefulness syndrome

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Brain Diseases; Persistent Vegetative State; Unconsciousness; Central Nervous System Diseases; Coma; Consciousness Disorders; Disease

Condition Hierarchy (Ancestors)

Nervous System Diseases; Brain Damage, Chronic; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Study Officials

• Haibo Di

  International Vegetative State and Consciousness Science Institute,Hangzhou Normal University

  STUDY DIRECTOR

• Anqi Wang

  International Vegetative State and Consciousness Science Institute,Hangzhou Normal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Until the end of the protocol, all three assessors were blinded to the scores acquired by the other assessors.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 11, 2022
• Study Start: December 20, 2021
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)