Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062473) titled 'A Study of Brain Microstructure Using an Advanced MRI Technique' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Kyoto university

Condition: Condition - neurological disorders, such as Parkinson's disease and epilepsy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to investigate the feasibility, measurement reproducibility, and potential clinical utility of brain microstructural assessment using Soma and Neurite Density Imaging in healthy participants and patients with neurological disorders, including Parkinson's disease and epilepsy. In healthy participants, imaging and analysis methods will be optimized, and the normal brain distribution, age-related changes, and reproducibility of Diffusion MRI-derived metrics will be evaluated. In patients with neurological disorders, Diffusion MRI-derived metrics in lesions or disease-related brain regions will be compared with those in healthy participants or corresponding contralateral regions. Associations with clinical symptoms, disease severity, disease duration, imaging and physiological findings, pathological findings, treatment, and clinical course will also be explored. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Healthy participants and patients with neurological disorders, including Parkinson's disease and epilepsy, will undergo brain MRI including Diffusion MRI using a 3-T MRI scanner. The Diffusion MRI acquisition time will vary depending on the imaging protocol and will generally range from approximately 5 to 20 minutes.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Healthy participants aged 18 years or older, or patients with neurological disorders, including Parkinson's disease, epilepsy and brain tumors, who have received sufficient information about the study and provided written informed consent. Key exclusion criteria - Individuals with a severely impaired general condition, claustrophobia, suspected early pregnancy, MRI-incompatible metallic implants or medical devices, inability to remain still during MRI, or any other condition considered by the investigators to make participation inappropriate. Target Size - 400

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 04 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071502

Disclaimer: Curated by HT Syndication.