Disorder of ConsciousnessNCT04471753
Target Behaviours to Identify Minimally Conscious State Patients
An observational study of Disorder of Consciousness and Minimally Conscious State, run by Hangzhou Normal University at 1 site in China.
Trial summary
To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Disorder of Consciousness, Minimally Conscious State
- What is being tested?
- Coma Recovery Scale-Revised
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 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 84 years
- All sexes
- Adult, Older adult
Study population: All patients were assessed by the Coma Recovery Scale-Revised for several times with seven days.
Who may be able to join
- Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.
Who cannot join
- Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment were excluded.
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: Target Behaviours to Identify Minimally Conscious State Patients by Using Coma Recovery Scale-Revised
To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery Scale-Revised assessment of minimally conscious state diagnosis and evidence for the simplification of Coma Recovery Scale-Revised in the future.
Read the detailed description
Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome patients were distinguished.
- Being tested
- Coma Recovery Scale-Revised
- Keywords
- disorders of consciousness, Coma Recovery Scale-revision, minimally conscious state
- 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-RevisedBehavioural
Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished.
| Study group | Role | What they receive |
|---|---|---|
| Patients with disorders of consciousness | Patients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units. Receives: Behavioral: Coma Recovery Scale-Revised |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised
The Coma Recovery Scale-Revised has 23 items, which evaluate the patients' auditory, visual, motor, oromotor/verbal, communication, and arousal functions. For each subscale, the lower score reflects reflexivity related to the brain stem, while the higher score reflects non-reflexivity related to higher cortical functions.
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Aug 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Prospective
- Enrolment
- 215 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
- NCT04471753
- Sponsor's protocol ID
- 2020N39286
- Status last verified
- Jul 2020
- First submitted
- 12 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.
PubMed 28543735American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.
PubMed 21112421
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Behaviours to Identify Minimally Conscious State Patients by Using Coma Recovery Scale-Revised
- ClinicalTrials.gov ID
- NCT04471753
- Acronym / sponsor ID
- 2020N39286
- Keywords
- disorders of consciousness, Coma Recovery Scale-revision, minimally conscious state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 15 Jul 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.
To analyse the frequency of the consciousness behaviour response for patients with minimally conscious state of Coma Recovery Scale-Revised items, as well as the necessary items for obtaining higher accuracy. In addition, providing target behaviours for Coma Recovery Scale-Revised assessment of minimally conscious state diagnosis and evidence for the simplification of Coma Recovery Scale-Revised in the future.
Detailed description
Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using Coma Recovery Scale-Revised five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome patients were distinguished.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with disorders of consciousness | – | Behavioral: Coma Recovery Scale-RevisedPatients with medical diagnosis of prolonged disorders of consciousness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients were assessed by the Coma Recovery Scale-Revised for several times with seven days.
Key inclusion criteria (1 listed)
- Patients with medical diagnosis of prolonged disorders of consciuosness (≥28 days) were included in neurosurgery, neurology, and neurorehabilitation units.
Key exclusion criteria (1 listed)
- Patients who used neuromuscular blockers or sedatives within 72 hours of enrolment were excluded.
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-RevisedData were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished. | Behavioural | Patients with disorders of consciousness |
Primary outcome
Coma Recovery Scale-Revised
Time frame: Within 7 days
The Coma Recovery Scale-Revised has 23 items, which evaluate the patients' auditory, visual, motor, oromotor/verbal, communication, and arousal functions. For each subscale, the lower score reflects reflexivity related to the brain stem, while the higher score reflects non-reflexivity related to higher cortical functions.
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 15 Jul 2020.
- Background: PubMed 28543735Wannez S, Heine L, Thonnard M, Gosseries O, Laureys S; Coma Science Group collaborators. The repetition of behavioral assessments in diagnosis of disorders of consciousness. Ann Neurol. 2017 Jun;81(6):883-889. doi: 10.1002/ana.24962.
- Results publication: PubMed 21112421American Congress of Rehabilitation Medicine, Brain Injury-Interdisciplinary Special Interest Group, Disorders of Consciousness Task Force; Seel RT, Sherer M, Whyte J, Katz DI, Giacino JT, Rosenbaum AM, Hammond FM, Kalmar K, Pape TL, Zafonte R, Biester RC, Kaelin D, Kean J, Zasler N. Assessment scales for disorders of consciousness: evidence-based recommendations for clinical practice and research. Arch Phys Med Rehabil. 2010 Dec;91(12):1795-813. doi: 10.1016/j.apmr.2010.07.218.
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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 1 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 15 Jul 2020. 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?
Coma Recovery Scale-Revised (time frame: Within 7 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 NCT04471753, which also lists 2 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 15 Jul 2020.