ClinicalTrials.gg
Sign In
CompletedNCT05496985Updated Aug 11, 2022

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

An interventional study of Simplified Evaluation of CONsciousness Disorders (SECONDs) in Brain Diseases, Vegetative State and Unconsciousness, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-11.

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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2021, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

Read the detailed description

To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs

02

Conditions studied

  • Brain Diseases
  • Vegetative State
  • Unconsciousness
  • Central Nervous System Diseases

Keywords

  • coma
  • disorder of consciousness
  • behavioral scale
  • rehabilitation
  • diagnosis
03

In context

Brain Diseases

502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.

This study's enrollment of 49 is below the median of 66 across 339 interventional studies indexed under Brain Diseases.

Browse Brain Diseases 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
18 Years to 85 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

  • Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
  • Age: 18-85 years old;
  • No history of other neurological or psychiatric deficits;
  • Ability to speak Chinese fluently;
  • Medical stability (e.g., absence of mechanical ventilation, sedation, infection)

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Patients in coma

    Patients in coma were assessed by the SECONDs and CRS-R for five days.

    Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

  • Experimental
    Patients in unresponsive wakefulness syndrome

    Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days.

    Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

  • Experimental
    Patients in minimally conscious state

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

    Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)

  • Experimental
    Patients in emerge from the minimally conscious state

    Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five 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) and Coma Recovery Scale-Revised (CRS-R)

06

What researchers measure

Primary outcomes

  1. Assess the reliability and validity of the Chinese version of the SECONDs

    The reliability and validity of the Chinese version of the SECONDs were evaluated by calculating the weighted Cohen's Kappa and Spearman coefficients of the differences between SECONDs and CRS-R in the diagnosis of MCS and UWS patients

    Time frame: Within 10 days

  2. Diagnose the level of consciousness in patients through SECONDs and CRS-R

    Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Simplified Evaluation of CONsciousness Disorders (SECONDs).

    Time frame: Within 10 days

  3. Diagnose the level of consciousness in patients through CRS-R

    Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Coma Recovery Scale-Revised (CRS-R).

    Time frame: Within 10 days

07

Study locations

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 Dec 2021 to primary completion in Mar 2022, 2 months.

Of 99 non-industry interventional studies with no phase under Brain Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's 2 months is below that.

Counting every sponsor, half of 117 studies reached it within 33 months; a quarter within 14 and three quarters within 54.

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

Registered
Aug 1, 2022
First posted
Aug 11, 2022
StartActual
Dec 20, 2021
Primary completionActual
Mar 14, 2022
CompletionActual
Mar 14, 2022
Last update
Aug 11, 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 Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05496985
Lead sponsor
Hangzhou Normal University
Responsible party
Haibo Di (professor, Hangzhou Normal University) — Principal investigator
First posted
Aug 11, 2022
Start date
Dec 20, 2021
Primary completion
Mar 14, 2022
Completion
Mar 14, 2022
Last update
Aug 11, 2022

Study contacts

Haibo Di
study director · International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
Anqi Wang
principal investigator · International Vegetative State and Consciousness Science Institute,Hangzhou Normal University

Oversight

Data monitoring committee
No
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 Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Diseases →

Other studies from this sponsor

Hangzhou Normal University

Start the discussion