Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062097) titled 'Prospective Study of Body Weight and Energy Balance in People with Parkinson's Disease Before and After Initiation of Device-Aided Therapies' on July 10.

Study Type: Observational

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Parkinson's disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Parkinson's disease (PD) is associated with progressive body weight loss in approximately half of patients over the course of the disease, and patients with marked weight loss tend to experience greater deterioration in motor symptoms and poorer clinical outcomes. In contrast, weight gain has been consistently reported following deep brain stimulation (DBS), a device-aided therapy (DAT) for advanced PD. Elucidating the mechanisms underlying these changes and establishing effective strategies to maintain an appropriate body weight are therefore important clinical challenges.

The aim of this study is to investigate the factors contributing to body weight loss in advanced PD and to body weight changes following the initiation of device-aided therapies (DAT), including DBS and continuous subcutaneous foslevodopa/foscarbidopa infusion (CSCI), with a particular focus on energy metabolism. Basic objectives2 - Others

Eligibility: Age-lower limit - 30 years-old = Gender - Male and Female Key inclusion criteria - Patients with PD who attend the Department of Neurology, Juntendo University Hospital, between the date of study approval and March 31, 2028, and who are scheduled to undergo either subthalamic nucleus deep brain stimulation (STN-DBS) implantation or initiation of continuous subcutaneous carbidopa/levodopa infusion (CSCI) within 3 months at the same institution will be eligible for enrollment. Inclusion Criteria 1. Age between 30 and 75 years at the time of obtaining informed consent. 2. Diagnosed with clinically established PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease. 3. Able to provide written informed consent voluntarily after receiving a full explanation of the study and demonstrating adequate understanding of its contents. Key exclusion criteria - Exclusion Criteria Patients with severe renal, hepatic, cardiac, or respiratory dysfunction. Patients with poorly controlled diabetes mellitus. Pregnant or breastfeeding women. Patients who are unable to undergo the examinations required for this study. Patients who are considered unsuitable for participation in this study by the principal investigator. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 01 Day Date of IRB - 2026 Year 06 Month 23 Day Anticipated trial start date - 2026 Year 07 Month 13 Day Last follow-up date - 2030 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071017

Disclaimer: Curated by HT Syndication.