Brain DiseasesNCT05496985
Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
A study testing Simplified Evaluation of CONsciousness Disorders (SECONDs) in people with Brain Diseases and Vegetative State, run by Hangzhou Normal University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Diseases, Vegetative State, Unconsciousness
- What is being tested?
- Simplified Evaluation of CONsciousness Disorders (SECONDs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang
About this study
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
- Being tested
- Simplified Evaluation of CONsciousness Disorders (SECONDs)
- Keywords
- coma, disorder of consciousness, behavioral scale, rehabilitation, diagnosis
- Medical subject headings
- Brain Diseases, Persistent Vegetative State, Unconsciousness, Central Nervous System Diseases, Coma, Consciousness Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified Evaluation of CONsciousness Disorders (SECONDs)Diagnostic test
All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)
| Study group | Role | What they receive |
|---|---|---|
| Patients in coma | Experimental | Patients in coma were assessed by the SECONDs and CRS-R for five days. Receives: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) |
| Patients in unresponsive wakefulness syndrome | Experimental | Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days. Receives: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) |
| Patients in minimally conscious state | Experimental | Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days. Receives: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) |
| Patients in emerge from the minimally conscious state | Experimental | Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days. Receives: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 10 days
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).
Measured: Within 10 days
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).
Measured: Within 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start20 Dec 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis \[17\], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Di, Hangzhou Normal University
- Investigators
- Haibo Di, Study director, International Vegetative State and Consciousness Science Institute,Hangzhou Normal UniversityAnqi Wang, Principal investigator, International Vegetative State and Consciousness Science Institute,Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496985
- Sponsor's protocol ID
- YCYY-20211021-003
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
- ClinicalTrials.gov ID
- NCT05496985
- Acronym / sponsor ID
- YCYY-20211021-003
- Keywords
- coma, disorder of consciousness, behavioral scale, rehabilitation, diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis [17], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
| Arm | Type | Receives |
|---|---|---|
| Patients in coma | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients in coma were assessed by the SECONDs and CRS-R for five days. |
| Patients in unresponsive wakefulness syndrome | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days. |
| Patients in minimally conscious state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days. |
| Patients in emerge from the minimally conscious state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplified Evaluation of CONsciousness Disorders (SECONDs)All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R) | Diagnostic test | Patients in coma, Patients in emerge from the minimally conscious state, Patients in minimally conscious state, Patients in unresponsive wakefulness syndrome |
Primary outcome
Assess the reliability and validity of the Chinese version of the SECONDs
Time frame: Within 10 days
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
Diagnose the level of consciousness in patients through SECONDs and CRS-R
Time frame: Within 10 days
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).
Diagnose the level of consciousness in patients through CRS-R
Time frame: Within 10 days
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified Evaluation of CONsciousness Disorders (SECONDs) in people with Brain Diseases and Vegetative State, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the reliability and validity of the Chinese version of the SECONDs (time frame: Within 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.