Minimally Conscious StateNCT04687553
Validation of the Chinese Version of the SECONDs
A study testing Simplified Evaluation of CONsciousness Disorders (SECONDs) in people with Minimally Conscious State 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 English into Chinese and determine the validity of this Chinese version Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Minimally Conscious State, Vegetative State
- What is being tested?
- Simplified Evaluation of CONsciousness Disorders (SECONDs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 1 Jul 2021
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, 310036
About this study
Official title: Validation of the Chinese Version of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
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.
- Conditions
- Minimally Conscious State, Vegetative State
- Being tested
- Simplified Evaluation of CONsciousness Disorders (SECONDs)
- Keywords
- disorders of consciousness, vegetative state, minimally conscious state, consciousness
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients with vegetative state | Experimental | Patients with vegetative state were assessed by the SECONDs and CRS-R for two days. Receives: Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs) |
| Patients with minimally conscious state | Experimental | Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two 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.
The level of consciousness in DOC patients
All patients were classified as the MCS and VS by the Coma recovery scale-revised
Measured: Within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start10 Nov 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Conscious StateStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Wang, Hangzhou Normal University
- Investigators
- Haibo Di, Pro., Study chair, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687553
- Sponsor's protocol ID
- 2020W356354
- Status last verified
- Jul 2022
- First submitted
- 8 Dec 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Chinese Version of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
- ClinicalTrials.gov ID
- NCT04687553
- Acronym / sponsor ID
- 2020W356354
- Conditions
- Minimally Conscious State, Vegetative State
- Keywords
- disorders of consciousness, vegetative state, minimally conscious state, consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 29 Dec 2020 (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 English into Chinese and determine the validity of this Chinese version
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Patients with vegetative state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients with vegetative state were assessed by the SECONDs and CRS-R for two days. |
| Patients with minimally conscious state | Experimental | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
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) | Diagnostic test | Patients with minimally conscious state, Patients with vegetative state |
Primary outcome
The level of consciousness in DOC patients
Time frame: Within 2 days
All patients were classified as the MCS and VS by the Coma recovery scale-revised
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 8 Jul 2022.
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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, Pro. study chair
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 Minimally Conscious State 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 4 inclusion and 6 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 8 Jul 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?
The level of consciousness in DOC patients (time frame: Within 2 days). 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 8 Jul 2022.