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

Primary Purpose

Minimally Conscious State, Vegetative State

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Nociception Coma Scale (NCS)

About this trial

This is an interventional diagnostic trial for Minimally Conscious State focused on measuring disorders of consciousness, vegetative state, minimally conscious state, consciousness, pain assessment, nociception test

Eligibility Criteria

19 Years - 53 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

vegetative state

minimally conscious state

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03494218

First Posted

April 3, 2018

Last Updated

April 9, 2018

Sponsor

Hangzhou Normal University

1. Study Identification

Unique Protocol Identification Number

NCT03494218

Brief Title

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

Official Title

Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 28, 2017 (Actual)

Primary Completion Date

February 2, 2018 (Actual)

Study Completion Date

March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hangzhou Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

The assessment and early diagnosis of pain is of great importance for pain management and treatment in patients with disorders of consciousness. The Nociception Coma Scale (- Revised) is only applicable to assess pain of DOC patients in international clinical setting. The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version. To test internal reliability and inter-rater reliability, both rater A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability, rater A assessed all patients repeatedly on day 2. 'Faces, Legs, Activity, Cry, Consolability' (FLACC) was used to analysis concurrent validity by rater A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Minimally Conscious State, Vegetative State

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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)

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vegetative state

Arm Type

Experimental

Arm Description

Arm Title

minimally conscious state

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Nociception Coma Scale (NCS)

Other Intervention Name(s)

the Face Legs Activity Cry and Consolability (FLACC)

Intervention Description

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

Primary Outcome Measure Information:

Title

The level of perception of pain in DOC patients

Description

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

Time Frame

Within 2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

53 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haibo Di, Pro

Organizational Affiliation

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Official's Role

Study Chair

Facility Information:

Facility Name

International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

3100036

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22906615

Citation

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.

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

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