Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062543) titled 'A study examining neurological findings useful for diagnosing functional neurological disorder' on Aug. 31.
Study Type:
Observational
Primary Sponsor:
Institute - National Center of Neurology and Psychiatry National Center
Condition:
Condition - Functional neurological disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to prospectively evaluate the diagnostic accuracy (sensitivity and specificity) of multiple positive signs for differentiating functional weakness from organic weakness, and to assess the inter-rater agreement (reliability) of these positive signs among multiple physician evaluators.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged eighteen years or older presenting with muscle weakness or sensory disturbance as neurological symptoms and who are able to undergo neurological examination and manual muscle testing.
Key exclusion criteria - Participants meeting any of the following criteria will be excluded.
1 Patients with severe cognitive impairment that makes it difficult to understand the study or to provide informed consent.
2 Patients with aphasia that interferes with understanding the study or undergoing neurological examination.
3 Patients with severe psychiatric disorders that make participation in the study or accurate assessment difficult.
4 Patients with other comorbid conditions that make accurate evaluation using neurological examination including manual muscle testing difficult.
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 22 Day
Date of IRB - 2026 Year 01 Month 21 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069215
Disclaimer: Curated by HT Syndication.