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CompletedNCT03494218Updated Apr 11, 2018

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

An interventional study of Nociception Coma Scale (NCS) in Minimally Conscious State and Vegetative State, sponsored by Hangzhou Normal University. Completed at 1 site in China. Open to participants aged 19 Years to 53 Years. Per ClinicalTrials.gov, last updated 2018-04-11.

Sponsored by Hangzhou Normal University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
19 Years to 53 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Minimally Conscious State
  • Vegetative State

Keywords

  • disorders of consciousness
  • vegetative state
  • minimally conscious state
  • consciousness
  • pain assessment
  • nociception test
03

In context

Persistent Vegetative State

88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.

This study's enrollment of 62 is above the median of 30 across 55 interventional studies indexed under Persistent Vegetative State.

Browse Persistent Vegetative State studies →

Lead sponsor

Hangzhou Normal University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 53 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    vegetative state

    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)

  • Experimental
    minimally conscious state

    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

  • Diagnostic testNociception Coma Scale (NCS)

    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)

06

What researchers measure

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

    Time frame: Within 2 days

07

Study locations

1 site
  • International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
    Hangzhou, Zhejiang 3100036, China
08

References and documents

Publications

  • 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. PubMed 22906615 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03494218
Lead sponsor
Hangzhou Normal University
Responsible party
Jing Wang (Dr, Hangzhou Normal University) — Principal investigator
First posted
Apr 11, 2018
Start date
Oct 28, 2017
Primary completion
Feb 2, 2018
Completion
Mar 1, 2018
Last update
Apr 11, 2018

Study contacts

Haibo Di, Pro
study chair · International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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