Reliability and Validity of the NCS (NCS-R)-Chinese Version

NCT03494218 | Completed DMC

• 1 other identifier: 2017R423055
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version.

Conditions

Minimally Conscious State; Vegetative State

Keywords

disorders of consciousness; vegetative state; minimally conscious state; consciousness; pain assessment; nociception test

Outcome Measures

Primary Outcomes (1)

• The level of perception of pain in DOC patients

  This original NCS consists of four subscales to assess motor, verbal, visual and facial behavioral responses and each subscale score ranges from 0 to 3

  Within 2 days

Study Arms (2)

vegetative state

EXPERIMENTAL

patients with vegetative state lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.

Diagnostic Test: Nociception Coma Scale (NCS)

minimally conscious state

EXPERIMENTAL

Patients with minimally conscious state display inconsistent, but reproducible and discernible signs of awareness using CRS-R. The nailbed pressure was applied for 5 seconds and ended as soon as the behavioral response were captured. The raters recorded patients' behavioral responses using Nociception Coma Scale (NCS) during 10 seconds after each noxious stimulus.

Diagnostic Test: Nociception Coma Scale (NCS)

Interventions

Nociception Coma Scale (NCS) DIAGNOSTIC_TEST

Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC.

Also known as: the Face Legs Activity Cry and Consolability (FLACC)

minimally conscious state; vegetative state

Eligibility Criteria

• Age: 19 Years - 53 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age ≥ 18 years old;
• no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
• the presence of periods of eye opening (indicating wakefulness and rest cycles);
• a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks.

You may not qualify if:

• Coma;
• documented history of prior brain injury;
• psychiatric or neurologic illness;
• neuromuscular blocking agents or sedative drugs administered within the prior 24 hours;
• no documented history of a prior coma, critical illness or unstable medical condition;
• upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores \<1).

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 (1)

• 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

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Haibo Di, Pro

  International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of NCS-R (A1). Meanwhile, to assess the concurrent validity, the scores of the FLACC were recorded together with NCS-R by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of NCS-R on day 2 (A2)

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 11, 2018
• Study Start: October 28, 2017
• Primary Completion: February 2, 2018
• Study Completion: March 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

CN (1)