Tokyo, June 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061985) titled 'Reliability and Validity of the Japanese Version of the Nociception Coma Scale-Revised: A Pain Assessment Tool for Patients with Impaired Consciousness' on June 20.
Study Type:
Observational
Primary Sponsor:
Institute - Hamamatsu Medical Center
Condition:
Condition - Cerebrovascular Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 18
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 Size - 53
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070930
Disclaimer: Curated by HT Syndication.
