Validation of the Chinese Version of the SECONDs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05496985

Brain Diseases Vegetative State Unconsciousness +1 more

COMPLETED NA

Reliability and Validity of the NCS (NCS-R)-Chinese Version

NCT03494218

Minimally Conscious State Vegetative State

COMPLETED NA

Diagnostic Accuracy of the Vegetative and Minimally Conscious State

NCT04139239

Disorder of Consciousness Minimally Conscious State

COMPLETED

Behavioral Assessment of Nociception on NCS-R

NCT04137497

Disorder of Consciousness Unresponsive Wakefulness Syndrome Minimally Conscious State

COMPLETED

Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation

NCT06515132

Disorder of Consciousness Spinal Cord Stimulation

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Minimally Conscious State Vegetative State

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with vegetative state

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

Group Type EXPERIMENTAL

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Intervention Type DIAGNOSTIC_TEST

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

Patients with minimally conscious state

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

Group Type EXPERIMENTAL

Simplified Evaluation of CONsciousness Disorders (SECONDs)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simplified Evaluation of CONsciousness Disorders (SECONDs)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No