Validation of the Chinese Version of the SECONDs

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

The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version

Study Overview

• Status: Completed
• Conditions: Minimally Conscious State; Vegetative State
• Intervention / Treatment: Diagnostic test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Detailed Description

The assessment is of great importance for the management and treatment in patients with disorders of consciousness. The Simplified Evaluation of CONsciousness Disorders is a useful tool to assess consciousness of DOC patients in bedside. The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version. To test internal reliability and inter-rater reliability, both rater A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability, rater A assessed all patients repeatedly on day 2.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310036
      • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age ≥ 16 years old;
• no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
• the presence of periods of eye opening (indicating wakefulness and rest cycles);
• a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.

Exclusion Criteria:

• Coma;
• documented history of prior brain injury;
• psychiatric or neurologic illness;
• neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
• no documented history of a prior coma, critical illness or unstable medical condition;
• upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores <1).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with vegetative state; Patients with vegetative state were assessed by the SECONDs and CRS-R for two days.	Diagnostic test: Simplified Evaluation of CONsciousness Disorders (SECONDs); All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Experimental: Patients with minimally conscious state; Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days.	Diagnostic test: Simplified Evaluation of CONsciousness Disorders (SECONDs); All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of consciousness in DOC patients	All patients were classified as the MCS and VS by the Coma recovery scale-revised	Within 2 days

Collaborators and Investigators

• Sponsor: Hangzhou Normal University
• Investigators: Study Chair: Haibo Di, Pro., International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: minimally conscious state; disorders of consciousness; consciousness; vegetative state
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Unconsciousness; Consciousness Disorders; Persistent Vegetative State
• Other Study ID Numbers: 2020W356354

Drug and device information, study documents

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