UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061985 |
|---|---|
| Receipt number | R000070930 |
| Scientific Title | Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness |
| Date of disclosure of the study information | 2026/06/20 |
| Last modified on | 2026/06/20 12:08:12 |
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Basic information
Public title
Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness
Acronym
Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness
Scientific Title
Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness
Scientific Title:Acronym
Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness
Region
| Japan |
Condition
Condition
Cerebrovascular Disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to develop a Japanese version of the NCS-R, examine its reliability and validity, and determine normative values and cutoff values for discriminating nociceptive from non-nociceptive stimulation according to the severity of disorders of consciousness.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Test-retest reliability: The Japanese version of the NCS-R, administered twice on the same day by Rater A
Key secondary outcomes
Inter-rater reliability: The Japanese version of the NCS-R, assessed by Rater A and Rater B on the same day
Concurrent validity: The Japanese version of the NCS-R, the Japanese version of the FLACC Behavioral Assessment Scale (Face, Legs, Activity, Cry, Consolability), and the Japanese version of the Critical-Care Pain Observation Tool (CPOT-J), all assessed by Rater A on the same day
Cutoff Values: Japanese Version of the NCS-R When Rater A Presented Invasive and Non-Invasive Stimuli
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older
Diagnosis of unresponsive wakefulness syndrome (UWS), minimally conscious state minus (MCS-), or minimally conscious state plus (MCS+) based on the Japanese version of the Coma Recovery Scale-Revised (CRS-R).
No use of muscle relaxants, analgesics, or sedatives within 24 hours prior to the assessment
Key exclusion criteria
Diagnosed as Emerged from Minimal Conscious State (EMCS) based on the 2 consecutive CRS-R assessments performed
Presence of neurodegenerative disease (e.g., dementia)
History of psychiatric disorders
Presence of mechanical ventilation
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kitano |
Organization
Hamamatsu Medical Center
Division name
Department of Rehabilitation Technology
Zip code
432-8580
Address
328 Tomizuka-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
TEL
0570-07-1113
kitano.hmc@gmail.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kitano |
Organization
Hamamatsu Medical Center
Division name
Department of Rehabilitation Technology
Zip code
432-8580
Address
328 Tomizuka-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
TEL
0570-07-1113
Homepage URL
kitano.hmc@gmail.com
Sponsor or person
Institute
Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical Center
Address
328 Tomizuka-cho, Chuo Ward, Hamamatsu City, Shizuoka Prefecture
Tel
0570-07-1113
kitano.hmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
53
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070930
