Behavioral Assessment of Nociception on NCS-R

Sponsor
Hangzhou Normal University (Other)
Overall Status
Completed
CT.gov ID
NCT04137497
Collaborator
(none)
140
1
21.8
6.4

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)

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

Study Type:
Observational
Actual Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Behavioral Assessment of Nociception on the Nociception Coma Scale-Revised in Patients With Disorders of Consciousness: A Sign of Consciousness
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
May 25, 2019
Actual Study Completion Date :
May 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Patients with disorders of consciousness

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.

Patients with unresponsive wakefulness syndrome

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.

Patients with minimally conscious state

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.

Outcome Measures

Primary Outcome Measures

  1. Nociception Coma Scale-Revised [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 84 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 International Vegetative State and Consciousness Science Institute, Hangzhou Normal University Hangzhou Zhejiang China 3100036

Sponsors and Collaborators

  • Hangzhou Normal University

Investigators

  • Study Chair: Haibo Di, Pro., International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jing Wang, Principal Investigator, Hangzhou Normal University
ClinicalTrials.gov Identifier:
NCT04137497
Other Study ID Numbers:
  • 2017N54965
First Posted:
Oct 24, 2019
Last Update Posted:
Nov 14, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jing Wang, Principal Investigator, Hangzhou Normal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2019