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CompletedNCT04687553Updated Jul 8, 2022

Validation of the Chinese Version of the SECONDs

An interventional study of Simplified Evaluation of CONsciousness Disorders (SECONDs) in Minimally Conscious State and Vegetative State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Minimally Conscious State
  • Vegetative State

Keywords

  • disorders of consciousness
  • vegetative state
  • minimally conscious state
  • consciousness
03

In context

Persistent Vegetative State

88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.

This study's enrollment of 120 is above the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.

Browse Persistent Vegetative State studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Patients with vegetative state

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

    Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

  • Experimental
    Patients with minimally conscious state

    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

  • Diagnostic testSimplified Evaluation of CONsciousness Disorders (SECONDs)

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

06

What researchers measure

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

    Time frame: Within 2 days

07

Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 310036, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2020 to primary completion in Jul 2021, 7 months.

Of 23 interventional studies with no phase under Persistent Vegetative State, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 72. This study's 7 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2020
First posted
Dec 29, 2020
StartActual
Nov 10, 2020
Primary completionActual
Jul 1, 2021
CompletionActual
Jul 1, 2021
Last update
Jul 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04687553
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Principal Investigator, Hangzhou Normal University) — Principal investigator
First posted
Dec 29, 2020
Start date
Nov 10, 2020
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021
Last update
Jul 8, 2022

Study contacts

Haibo Di, Pro.
study chair · International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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