Back to results

Validation of the Chinese Version of the SECONDs

Primary Purpose

Minimally Conscious State, Vegetative State

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Simplified Evaluation of CONsciousness Disorders (SECONDs)

About this trial

This is an interventional diagnostic trial for Minimally Conscious State focused on measuring disorders of consciousness, vegetative state, minimally conscious state, consciousness

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with vegetative state

Patients with minimally conscious state

Arm Description

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

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

Outcomes

Primary Outcome Measures

The level of consciousness in DOC patients

All patients were classified as the MCS and VS by the Coma recovery scale-revised

Secondary Outcome Measures

Full Information

NCT ID

NCT04687553

First Posted

December 8, 2020

Last Updated

July 7, 2022

Sponsor

Hangzhou Normal University

1. Study Identification

Unique Protocol Identification Number

NCT04687553

Brief Title

Validation of the Chinese Version of the SECONDs

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

November 10, 2020 (Actual)

Primary Completion Date

July 1, 2021 (Actual)

Study Completion Date

July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hangzhou Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Minimally Conscious State, Vegetative State

Keywords

disorders of consciousness, vegetative state, minimally conscious state, consciousness

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with vegetative state

Arm Type

Experimental

Arm Description

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

Arm Title

Patients with minimally conscious state

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Intervention Description

All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)

Primary Outcome Measure Information:

Title

The level of consciousness in DOC patients

Description

All patients were classified as the MCS and VS by the Coma recovery scale-revised

Time Frame

Within 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haibo Di, Pro.

Organizational Affiliation

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Official's Role

Study Chair

Facility Information:

Facility Name

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310036

Country

China

12. IPD Sharing Statement

Learn more about this trial

Validation of the Chinese Version of the SECONDs

We'll reach out to this number within 24 hrs