Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061749) titled 'A Study on a New Ultrasound Test for Throat Muscle Movement: Application for the early detection of Swallowing Problem in Parkinson's Disease' on Aug. 15.
Study Type:
Observational
Primary Sponsor:
Institute - Kawasaki Medical School
Condition:
Condition - 1. Patients with suspected esophageal motility disorders who are scheduled to undergo high-resolution esophageal manometry as part of routine clinical care.
2. Patients diagnosed with Parkinson's disease (PD).
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - 1. Establishment of a non-invasive evaluation method through the validation of homology between HRM as the standard reference and novel ultrasonographic parameters.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients of either sex, aged 20 to 85 years, who have provided written informed consent to participate in this study, and who meet either of the following criteria:
[Study 1] Patients with suspected esophageal motility disorders who undergo HRM as part of routine clinical care.
[Study 2] Patients diagnosed with PD.
Key exclusion criteria - [Exclusion Criteria Common to All Groups]
(1) Patients with a history of aspiration pneumonia.
(2) Patients with fewer than 3 swallows in 30 seconds on the Repetitive Saliva Swallowing Test (RSST).
(3) Patients with organic lesions, such as esophageal stricture, detected by upper gastrointestinal endoscopy.
(4) Other patients judged by the attending physician to be ineligible for entry into this study.
[Exclusion Criteria Applicable Only to Study 1]
(5) Patients with upper esophageal sphincter (UES) dysfunction detected by HRM.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 31 Day
Anticipated trial start date - 2026 Year 09 Month 01 Day
Last follow-up date - 2028 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070663
Disclaimer: Curated by HT Syndication.