Behavioral Assessment of Nociception on NCS-R

NCT04137497 | Completed DMC

• 1 other identifier: 2017N54965
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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)

Conditions

Disorder of Consciousness; Unresponsive Wakefulness Syndrome; Minimally Conscious State

Keywords

disorders of consciousness; unresponsive wakefulness syndrome; minimally conscious state; Nociception Coma Scale-Revised

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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)

Interventions

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.

Patients with disorders of consciousness; Patients with minimally conscious state; Patients with unresponsive wakefulness syndrome

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hangzhou Normal University: lead

Study Sites (1)

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Hangzhou, Zhejiang, 3100036, China

Location

Related Publications (4)

• 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.

  PMID: 19854576 BACKGROUND

• 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.

  PMID: 22906615 BACKGROUND

• 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.

  PMID: 23603804 BACKGROUND

• 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.

  PMID: 30098792 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Study Officials

• Haibo Di, Pro.

  International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: August 1, 2017
• Primary Completion: May 25, 2019
• Study Completion: May 26, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

CN (1)