Minimally Conscious StateNCT03494218
Reliability and Validity of the NCS (NCS-R)-Chinese Version
A study testing Nociception Coma Scale (NCS) in people with Minimally Conscious State and Vegetative State, run by Hangzhou Normal University at 1 site in China.
Trial summary
The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version. Read more about this study
- Who is it for?
- Ages 19 to 53 years
- Conditions the study is for
- Minimally Conscious State, Vegetative State
- What is being tested?
- Nociception Coma Scale (NCS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2017to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
Hangzhou, Zhejiang, 3100036
About this study
Official title: Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version
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.
- Conditions
- Minimally Conscious State, Vegetative State
- Being tested
- Nociception Coma Scale (NCS)
- Keywords
- disorders of consciousness, vegetative state, minimally conscious state, consciousness, pain assessment, nociception test
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nociception Coma Scale (NCS)Diagnostic test
Also called the Face Legs Activity Cry and Consolability (FLACC)
Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Nociception Coma Scale (NCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start28 Oct 2017
- Primary completion2 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minimally Conscious StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Wang, Hangzhou Normal University
- Investigators
- Haibo Di, Pro, Study chair, International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494218
- Sponsor's protocol ID
- 2017R423055
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Nociception Coma Scale (-Revised)-Chinese Version
- ClinicalTrials.gov ID
- NCT03494218
- Acronym / sponsor ID
- 2017R423055
- Conditions
- Minimally Conscious State, Vegetative State
- Keywords
- disorders of consciousness, vegetative state, minimally conscious state, consciousness, pain assessment, nociception test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 2 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| vegetative state | Experimental | Diagnostic Test: Nociception Coma Scale (NCS)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. |
| minimally conscious state | Experimental | Diagnostic Test: Nociception Coma Scale (NCS)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. |
Who may qualify
- Ages
- 19 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nociception Coma Scale (NCS)Also: the Face Legs Activity Cry and Consolability (FLACC)Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC. | Diagnostic test | minimally conscious state, vegetative state |
Primary outcome
The level of perception of pain in DOC patients
Time frame: Within 2 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Background: PubMed 22906615Chatelle 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haibo Di, Pro study chair
International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nociception Coma Scale (NCS) in people with Minimally Conscious State and Vegetative State, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of perception of pain in DOC patients (time frame: Within 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03494218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.