Behavioral Assessment of Nociception on NCS-R

November 13, 2019 updated by: Jing Wang, Hangzhou Normal University

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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. The highest score was selected as the final bedside behavioral diagnosis of the patient's consciousness level. 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. The patient's specific behavioral performance was also recorded.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with disorders of consciousness
Diagnostic test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
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.
Patients with unresponsive wakefulness syndrome
Diagnostic test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
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.
Patients with minimally conscious state
Diagnostic test: The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nociception Coma Scale-Revised
Time Frame: Within 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Normal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Haibo Di, Pro., International Vegetative State and Consciousness Science Institute, Hangzhou Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017N54965

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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