Disorder of ConsciousnessNCT04137497
Behavioral Assessment of Nociception on NCS-R
An observational study of Disorder of Consciousness and Unresponsive Wakefulness Syndrome, run by Hangzhou Normal University at 1 site in China.
Trial summary
The aim of this study was to investigate the relationship between behaviorally assessed consciousness levels and responsiveness to nociception in patients with disorders of consciousness (DOC) Read more about this study
- Who is it for?
- Ages 20 to 84 years
- Conditions the study is for
- Disorder of Consciousness, Unresponsive Wakefulness Syndrome, Minimally Conscious State
- What is being tested?
- The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 26 May 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 20 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. The highest score was selected as the final bedside behavioral diagnosis of the patient's consciousness level. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines. The patient's specific behavioral performance was also recorded.
Who may be able to join
- (1) at least 18 years old
- (2) acquired brain injury
- (3) no neuromuscular blockers or sedatives used within 72 hours of enrollment.
Who cannot join
- (1) functional disorders caused by progressive mental diseases
- (2) persistent seizures
- (3) unstable vital signs
- and/or (4) 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: Behavioral Assessment of Nociception on the Nociception Coma Scale-Revised in Patients With Disorders of Consciousness: A Sign of Consciousness
The aim of this study was to investigate the relationship between behaviorally assessed consciousness levels and responsiveness to nociception in patients with disorders of consciousness (DOC)
Read the detailed description
Patients with a clinical consensus of DOC were enrolled. The Coma Recovery Scale-Revised (CRS-R) was used to assess the DOC patients' consciousness levels and the Nociception Coma Scale-Revised (NCS-R) was used to evaluate their pain response over one week. Furthermore, the relationship between behaviorally assessed consciousness levels and pain response was analyzed.
- Being tested
- The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
- Keywords
- disorders of consciousness, unresponsive wakefulness syndrome, minimally conscious state, Nociception Coma Scale-Revised
- 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.
The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)Diagnostic test
All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Patients with disorders of consciousness | Not described Receives: Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) | |
| Patients with unresponsive wakefulness syndrome | Not described Receives: Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) | |
| Patients with minimally conscious state | Not described Receives: Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nociception Coma Scale-Revised
The Nociception Coma Scale-Revised was used to evaluate the pain response of all patients in random order at least once. A score greater than or equal to 3 points indicated that the patient was responsive to pain stimulation, while a score greater than or equal to 4 points suggested that the patient might have pain perception related to consciousness.
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 posted24 Oct 2019
- Study start1 Aug 2017
- Primary completion25 May 2019
- Study completion26 May 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
- 140 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
- NCT04137497
- Sponsor's protocol ID
- 2017N54965
- Status last verified
- Nov 2019
- First submitted
- 22 Oct 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schnakers C, Chatelle C, Vanhaudenhuyse A, Majerus S, Ledoux D, Boly M, Bruno MA, Boveroux P, Demertzi A, Moonen G, Laureys S. The Nociception Coma Scale: a new tool to assess nociception in disorders of consciousness. Pain. 2010 Feb;148(2):215-219. doi: 10.1016/j.pain.2009.09.028. Epub 2009 Oct 24.
PubMed 19854576Chatelle C, Majerus S, Whyte J, Laureys S, Schnakers C. A sensitive scale to assess nociceptive pain in patients with disorders of consciousness. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1233-7. doi: 10.1136/jnnp-2012-302987. Epub 2012 Aug 20.
PubMed 22906615Sattin D, Pagani M, Covelli V, Giovannetti AM, Leonardi M. The Italian version of the Nociception Coma Scale. Int J Rehabil Res. 2013 Jun;36(2):182-6. doi: 10.1097/MRR.0b013e3283618d68.
PubMed 23603804Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Comprehensive Systematic Review Update Summary: Disorders of Consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Arch Phys Med Rehabil. 2018 Sep;99(9):1710-1719. doi: 10.1016/j.apmr.2018.07.002. Epub 2018 Aug 8.
PubMed 30098792
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
- Behavioral Assessment of Nociception on the Nociception Coma Scale-Revised in Patients With Disorders of Consciousness: A Sign of Consciousness
- ClinicalTrials.gov ID
- NCT04137497
- Acronym / sponsor ID
- 2017N54965
- Keywords
- disorders of consciousness, unresponsive wakefulness syndrome, minimally conscious state, Nociception Coma Scale-Revised
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 26 May 2019 (actual)
- First posted
- 24 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 the relationship between behaviorally assessed consciousness levels and responsiveness to nociception in patients with disorders of consciousness (DOC)
Detailed description
Patients with a clinical consensus of DOC were enrolled. The Coma Recovery Scale-Revised (CRS-R) was used to assess the DOC patients' consciousness levels and the Nociception Coma Scale-Revised (NCS-R) was used to evaluate their pain response over one week. Furthermore, the relationship between behaviorally assessed consciousness levels and pain response was analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with disorders of consciousness | – | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) |
| Patients with unresponsive wakefulness syndrome | – | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) |
| Patients with minimally conscious state | – | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R) |
Who may qualify
- Ages
- 20 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. The highest score was selected as the final bedside behavioral diagnosis of the patient's consciousness level. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines. The patient's specific behavioral performance was also recorded.
Key inclusion criteria (3 listed)
- (1) at least 18 years old
- (2) acquired brain injury
- (3) no neuromuscular blockers or sedatives used within 72 hours of enrollment.
Key exclusion criteria (4 listed)
- (1) functional disorders caused by progressive mental diseases
- (2) persistent seizures
- (3) unstable vital signs
- and/or (4) 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 |
|---|---|---|
| The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines. | Diagnostic test | Patients with disorders of consciousness, Patients with minimally conscious state, Patients with unresponsive wakefulness syndrome |
Primary outcome
Nociception Coma Scale-Revised
Time frame: Within 7 days
The Nociception Coma Scale-Revised was used to evaluate the pain response of all patients in random order at least once. A score greater than or equal to 3 points indicated that the patient was responsive to pain stimulation, while a score greater than or equal to 4 points suggested that the patient might have pain perception related to consciousness.
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 19854576Schnakers C, Chatelle C, Vanhaudenhuyse A, Majerus S, Ledoux D, Boly M, Bruno MA, Boveroux P, Demertzi A, Moonen G, Laureys S. The Nociception Coma Scale: a new tool to assess nociception in disorders of consciousness. Pain. 2010 Feb;148(2):215-219. doi: 10.1016/j.pain.2009.09.028. Epub 2009 Oct 24.
- Background: PubMed 22906615Chatelle C, Majerus S, Whyte J, Laureys S, Schnakers C. A sensitive scale to assess nociceptive pain in patients with disorders of consciousness. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1233-7. doi: 10.1136/jnnp-2012-302987. Epub 2012 Aug 20.
- Background: PubMed 23603804Sattin D, Pagani M, Covelli V, Giovannetti AM, Leonardi M. The Italian version of the Nociception Coma Scale. Int J Rehabil Res. 2013 Jun;36(2):182-6. doi: 10.1097/MRR.0b013e3283618d68.
- Background: PubMed 30098792Giacino JT, Katz DI, Schiff ND, Whyte J, Ashman EJ, Ashwal S, Barbano R, Hammond FM, Laureys S, Ling GSF, Nakase-Richardson R, Seel RT, Yablon S, Getchius TSD, Gronseth GS, Armstrong MJ. Comprehensive Systematic Review Update Summary: Disorders of Consciousness: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology; the American Congress of Rehabilitation Medicine; and the National Institute on Disability, Independent Living, and Rehabilitation Research. Arch Phys Med Rehabil. 2018 Sep;99(9):1710-1719. doi: 10.1016/j.apmr.2018.07.002. Epub 2018 Aug 8.
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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?
An observational study of Disorder of Consciousness and Unresponsive Wakefulness Syndrome, 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?
Nociception Coma 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 NCT04137497, 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.