Clinical trial NCT04137497: Behavioral Assessment of Nociception on NCS-R
Official title: Behavioral Assessment of Nociception on the Nociception Coma Scale-Revised in Patients With Disorders of Consciousness: A Sign of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Unresponsive Wakefulness Syndrome
Minimally Conscious State
Keywords: disorders of consciousness
unresponsive wakefulness syndrome
minimally conscious state
Nociception Coma Scale-Revised
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* (1) at least 18 years old
* (2) acquired brain injury
* (3) no neuromuscular blockers or sedatives used within 72 hours of enrollment.

Exclusion Criteria:

* (1) functional disorders caused by progressive mental diseases
* (2) persistent seizures
* (3) unstable vital signs
* and/or (4) double upper-limb frustration, fracture.

Primary outcomes:
measure: Nociception Coma Scale-Revised
timeFrame: Within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
affiliation: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
name: Haibo Di, Pro.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.