Disorder of ConsciousnessNCT04139239
Diagnostic Accuracy of the Vegetative and Minimally Conscious State
An observational study of Disorder of Consciousness and Minimally Conscious State, run by Hangzhou Normal University at 1 site in China.
Trial summary
The aim of this study was to investigate diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Disorder of Consciousness, Minimally Conscious State
- What is being tested?
- Coma Recovery Scale-revision
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 22 Oct 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with DOC chosen by clinician were included in the study at Department of Neurology and Rehabilitation center of hospital. All patients were diagnosed by the Coma Recovery Scale-revision (CRS-R) for five times at least within 10 days.
Who may be able to join
- at least 18 years old;
- acquired brain injury;
- no neuromuscular blockers or sedatives were used within 48 hours of enrollment.
Who cannot join
- there are functional disorders caused by progressive mental diseases;
- persistent seizures;
- unstable vital signs;
- double upper limb frustration, fracture.
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, 3100036
About this study
Official title: Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment
The aim of this study was to investigate diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment
Read the detailed description
In this study, DOC patients with clinical consensus of DOC were enrolled. The investigators used Coma Recovery Scale-revision (CRS-R) to assess consciousness levels for all DOC patients during ten days.
- Being tested
- Coma Recovery Scale-revision
- Keywords
- Disorders of consciousness, Coma Recovery Scale-revision, Diagnostic accuracy
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coma Recovery Scale-revisionDiagnostic test
Patients were assessed by Coma Recovery Scale-revision to detect the DOC patients enrolled by clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Patients with disorders of consciousness | Not described Receives: Diagnostic Test: Coma Recovery Scale-revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessed by the Coma Recovery Scale-Revised
All patients were assessed by the Coma Recovery Scale-Revised within 10 days to detect the consciousness level. CRS-R consists of six sub-scales with 23 items, which evaluate the patients' auditory, visual, motor, Oromotor/Verbal, communication and arousal functions. For each subscale, the lower score reflected reflexivity related to the brain stem, while the higher score reflected non-reflexivity related to higher cortical functions (0-23).
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 posted25 Oct 2019
- Study start1 Jul 2017
- Primary completion15 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 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, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139239
- Sponsor's protocol ID
- 2018N56745
- Status last verified
- Nov 2019
- First submitted
- 23 Oct 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farquhar I, Fairclough JA. Sciatic block in lower limb surgery. Injury. 1990 Mar;21(2):107-9. doi: 10.1016/0020-1383(90)90066-4.
PubMed 2351462van Erp WS, Lavrijsen JC, Vos PE, Bor H, Laureys S, Koopmans RT. The vegetative state: prevalence, misdiagnosis, and treatment limitations. J Am Med Dir Assoc. 2015 Jan;16(1):85.e9-85.e14. doi: 10.1016/j.jamda.2014.10.014.
PubMed 25528282Stender J, Gosseries O, Bruno MA, Charland-Verville V, Vanhaudenhuyse A, Demertzi A, Chatelle C, Thonnard M, Thibaut A, Heine L, Soddu A, Boly M, Schnakers C, Gjedde A, Laureys S. Diagnostic precision of PET imaging and functional MRI in disorders of consciousness: a clinical validation study. Lancet. 2014 Aug 9;384(9942):514-22. doi: 10.1016/S0140-6736(14)60042-8. Epub 2014 Apr 15.
PubMed 24746174Wang J, Hu X, Hu Z, Sun Z, Laureys S, Di H. The misdiagnosis of prolonged disorders of consciousness by a clinical consensus compared with repeated coma-recovery scale-revised assessment. BMC Neurol. 2020 Sep 12;20(1):343. doi: 10.1186/s12883-020-01924-9.
PubMed 32919461
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Vegetative and Minimally Conscious State: Clinical Consensus Versus Standardized Neurobehavioral Assessment
- ClinicalTrials.gov ID
- NCT04139239
- Acronym / sponsor ID
- 2018N56745
- Keywords
- Disorders of consciousness, Coma Recovery Scale-revision, Diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 25 Oct 2019 (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 investigate diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment
Detailed description
In this study, DOC patients with clinical consensus of DOC were enrolled. The investigators used Coma Recovery Scale-revision (CRS-R) to assess consciousness levels for all DOC patients during ten days.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with disorders of consciousness | – | Diagnostic Test: Coma Recovery Scale-revision |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with DOC chosen by clinician were included in the study at Department of Neurology and Rehabilitation center of hospital. All patients were diagnosed by the Coma Recovery Scale-revision (CRS-R) for five times at least within 10 days.
Key inclusion criteria (3 listed)
- at least 18 years old;
- acquired brain injury;
- no neuromuscular blockers or sedatives were used within 48 hours of enrollment.
Key exclusion criteria (4 listed)
- there are functional disorders caused by progressive mental diseases;
- persistent seizures;
- unstable vital signs;
- double upper limb frustration, fracture.
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 |
|---|---|---|
| Coma Recovery Scale-revisionPatients were assessed by Coma Recovery Scale-revision to detect the DOC patients enrolled by clinicians. | Diagnostic test | Patients with disorders of consciousness |
Primary outcome
Assessed by the Coma Recovery Scale-Revised
Time frame: Within 10 days
All patients were assessed by the Coma Recovery Scale-Revised within 10 days to detect the consciousness level. CRS-R consists of six sub-scales with 23 items, which evaluate the patients' auditory, visual, motor, Oromotor/Verbal, communication and arousal functions. For each subscale, the lower score reflected reflexivity related to the brain stem, while the higher score reflected non-reflexivity related to higher cortical functions (0-23).
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 14 Nov 2019.
- Background: PubMed 2351462Farquhar I, Fairclough JA. Sciatic block in lower limb surgery. Injury. 1990 Mar;21(2):107-9. doi: 10.1016/0020-1383(90)90066-4.
- Background: PubMed 25528282van Erp WS, Lavrijsen JC, Vos PE, Bor H, Laureys S, Koopmans RT. The vegetative state: prevalence, misdiagnosis, and treatment limitations. J Am Med Dir Assoc. 2015 Jan;16(1):85.e9-85.e14. doi: 10.1016/j.jamda.2014.10.014.
- Background: PubMed 24746174Stender J, Gosseries O, Bruno MA, Charland-Verville V, Vanhaudenhuyse A, Demertzi A, Chatelle C, Thonnard M, Thibaut A, Heine L, Soddu A, Boly M, Schnakers C, Gjedde A, Laureys S. Diagnostic precision of PET imaging and functional MRI in disorders of consciousness: a clinical validation study. Lancet. 2014 Aug 9;384(9942):514-22. doi: 10.1016/S0140-6736(14)60042-8. Epub 2014 Apr 15.
- Derived from this study: PubMed 32919461Wang J, Hu X, Hu Z, Sun Z, Laureys S, Di H. The misdiagnosis of prolonged disorders of consciousness by a clinical consensus compared with repeated coma-recovery scale-revised assessment. BMC Neurol. 2020 Sep 12;20(1):343. doi: 10.1186/s12883-020-01924-9.
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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
Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder of Consciousness and Minimally Conscious 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 3 inclusion and 4 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 14 Nov 2019. 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?
Assessed by the Coma Recovery Scale-Revised (time frame: Within 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139239, which also lists 4 linked publications.
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 14 Nov 2019.