Validation of the Chinese Version of the SECONDs

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687553
• Other study ID #: 2020W356354
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2022
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

Diagnostic Test:
• Simplified Evaluation of CONsciousness Disorders (SECONDs)
All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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