Minimally Conscious StateNCT03126929
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
An observational study of Minimally Conscious State and Vegetative State, run by Hangzhou Normal University.
Trial summary
This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R). Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Minimally Conscious State, Vegetative State
- What is being tested?
- Coma Recovery Scale-Revised and Glasgow Coma Scale
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 2017
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators chosen patients with VS, MCS, EMCS
Who may be able to join
- age above 18 years old
- any etiology
- pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)
Who cannot join
- 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
About this study
Official title: Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised
This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).
Read the detailed description
Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC
- Conditions
- Minimally Conscious State, Vegetative State
- Being tested
- Coma Recovery Scale-Revised and Glasgow Coma Scale
- Keywords
- disorders of consciousness, Vegetative state, Minimally conscious state, Emergence from MCS, Coma Recovery Scale-Revised
- 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.
Coma Recovery Scale-Revised and Glasgow Coma ScaleDiagnostic test
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)
| Study group | Role | What they receive |
|---|---|---|
| Vegetative state | patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS Receives: Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale | |
| Minimally conscious state | Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS Receives: Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale | |
| Emergence from MCS | Patients regain accurate communication and/or functional use of objects using CRS-R and GCS Receives: Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised for assess the level of consciousness
Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.
Measured: 24 hours(1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startMar 2012
- Primary completionMar 2017
- Study completionMar 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zhang, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126929
- Sponsor's protocol ID
- 2012/026/B
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised
- ClinicalTrials.gov ID
- NCT03126929
- Acronym / sponsor ID
- 2012/026/B
- Conditions
- Minimally Conscious State, Vegetative State
- Keywords
- disorders of consciousness, Vegetative state, Minimally conscious state, Emergence from MCS, Coma Recovery Scale-Revised
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Apr 2017 (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.
This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).
Detailed description
Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegetative state | – | Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scalepatients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS |
| Minimally conscious state | – | Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma ScalePatients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS |
| Emergence from MCS | – | Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma ScalePatients regain accurate communication and/or functional use of objects using CRS-R and GCS |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators chosen patients with VS, MCS, EMCS
Key inclusion criteria (3 listed)
- age above 18 years old
- any etiology
- pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)
Key exclusion criteria (3 listed)
- 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 |
|---|---|---|
| Coma Recovery Scale-Revised and Glasgow Coma ScalePatients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS) | Diagnostic test | Emergence from MCS, Minimally conscious state, Vegetative state |
Primary outcome
Coma Recovery Scale-Revised for assess the level of consciousness
Time frame: 24 hours(1 day)
Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.
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 25 Apr 2017.
- Individual participant dataSharing planned: Yes
Related trials for Minimally Conscious State
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Prognostication of Recovery in Early Disorders of Consciousness Study
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Not yet recruitingObservational study
Multimodal Assessment and Prognosis in Disorders of Consciousness After Severe Brain Injury (CyDoC-MAP)
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimally Conscious State and Vegetative State, run by Hangzhou Normal University.
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 3 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Coma Recovery Scale-Revised for assess the level of consciousness (time frame: 24 hours(1 day)). 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 25 Apr 2017.