Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2017-08-01
2019-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Patients with disorders of consciousness
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.
Patients with unresponsive wakefulness syndrome
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.
Patients with minimally conscious state
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* (2) acquired brain injury
* (3) no neuromuscular blockers or sedatives used within 72 hours of enrollment.
Exclusion Criteria
* (2) persistent seizures
* (3) unstable vital signs
* and/or (4) double upper-limb frustration, fracture.
20 Years
84 Years
ALL
No
Sponsors
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Hangzhou Normal University
OTHER
Responsible Party
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Jing Wang
Principal Investigator
Principal Investigators
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Haibo Di, Pro.
Role: STUDY_CHAIR
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Locations
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International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, China
Countries
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References
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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.
Chatelle 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.
Sattin 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.
Giacino 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.
Other Identifiers
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2017N54965
Identifier Type: -
Identifier Source: org_study_id
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