Validation of the Chinese Version of the SECONDs

NCT04687553 | Completed DMC

• 1 other identifier: 2020W356354
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Minimally Conscious State; Vegetative State

Keywords

disorders of consciousness; vegetative state; minimally conscious state; consciousness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with vegetative state

EXPERIMENTAL

Patients with vegetative state were assessed by the SECONDs and CRS-R for two days.

Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

Patients with minimally conscious state

EXPERIMENTAL

Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two 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)

Patients with minimally conscious state; Patients with vegetative state

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 310036, China

Location

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Haibo Di, Pro.

  International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of SECONDs (A1). Meanwhile, to assess the concurrent validity, the scores of the CRS-R were recorded together with SECONDs by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of SECONDs on day 2 (A2).

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 29, 2020
• Study Start: November 10, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

CN (1)