UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062473 |
|---|---|
| Receipt number | R000071502 |
| Scientific Title | Evaluation of Brain Microstructure Using Diffusion MRI Models |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/09 19:10:07 |
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Basic information
Public title
A Study of Brain Microstructure Using an Advanced MRI Technique
Acronym
Brain Microstructure MRI Study
Scientific Title
Evaluation of Brain Microstructure Using Diffusion MRI Models
Scientific Title:Acronym
DWI Brain Microstructure Study
Region
| Japan |
Condition
Condition
neurological disorders, such as Parkinson's disease and epilepsy
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are the brain distribution and measurement reproducibility of Diffusion MRI-derived microstructural metrics. In patients with neurological disorders, Diffusion MRI-derived metrics in lesions or disease-related brain regions will be compared with those in corresponding contralateral regions or healthy participants.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513760
diag_rad@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachi |
| Middle name | |
| Last name | Okuchi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medical Imaging Research
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513760
Homepage URL
diag_rad@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Kyoto university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071502
