Validation of the Chinese Version of the SECONDs | NCT04687553

Studies
Validation of the Chinese Version of the SECONDs

NCT04687553

Sponsor

Hangzhou Normal University

Status

Completed

Last Update Posted

Jul 8, 2022Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Minimally Conscious State
Vegetative State

Interventions

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 24, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2022

Last Update Posted Date

Jul 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Haibo Di, Pro.	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University		Hangzhou	Zhejiang	310036	China

Condition Browse Module

MeSH Terms

ID	Term
D018458	Persistent Vegetative State
D003244	Consciousness Disorders

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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).