Behavioral Assessment of Nociception on NCS-R

Disorder of Consciousness Clinical Trial

Official title:

Behavioral Assessment of Nociception on the Nociception Coma Scale-Revised in Patients With Disorders of Consciousness: A Sign of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137497
• Other study ID #: 2017N54965
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: May 26, 2019

Study information

• Verified date: November 2019
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 26, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorder of Consciousness
• Minimally Conscious State
• Persistent Vegetative State
• Unresponsive Wakefulness Syndrome

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	International Vegetative State and Consciousness Science Institute, Hangzhou Normal University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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):215-9. doi: 10.1016/j.pain.2009.09.028. Epub 2009 Oct 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 7 days