Behavioral Assessment of Nociception on NCS-R

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disorder of Consciousness, Unresponsive Wakefulness Syndrome, Minimally Conscious State

Intervention / Treatment
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* Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with disorders of consciousness<br> | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)<br>* 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.<br>|
| Patients with unresponsive wakefulness syndrome<br> | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)<br>* 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.<br>|
| Patients with minimally conscious state<br> | Diagnostic Test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disorders of consciousness, unresponsive wakefulness syndrome, minimally conscious state, Nociception Coma Scale-Revised