UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055137 |
|---|---|
| Receipt number | R000062985 |
| Scientific Title | Microstructural alterations in neurological diseases using 7 Tesla MRI |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/01/31 09:03:00 |
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Basic information
Public title
Microstructural alterations in neurological diseases using 7 Tesla MRI
Acronym
Microstructural alterations in neurological diseases using 7 Tesla MRI
Scientific Title
Microstructural alterations in neurological diseases using 7 Tesla MRI
Scientific Title:Acronym
Microstructural alterations in neurological diseases using 7 Tesla MRI
Region
| Japan |
Condition
Condition
Patients with Alzheimer's disease (AD), Mild Cognitive Impairment (MCI), Parkinson's disease (PD), Parkinson's syndromes, including Progressive supranuclear palsy (PSP) and cortico-basal syndrome (CBS); Spinocerebellar degeneration (SCD; multiple system atrophy) SCD; including Multiple system atrophy (MSA), REM Sleep behavior disorder (RBD), as well as patients with cerebrovascular disorders.
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Magnetic resonance imaging (MRI) has progressed over time, with the development of 7-tesla MRI, which can produce more detailed images than MRI currently used in clinical practice. 7-tesla MRI is expected to provide new findings useful for future medical treatment and clarification of pathological conditions as a cutting-edge device. The 7 Tesla MRI is a state-of-the-art device and is expected to provide new findings useful for future medical treatment and clarification of pathology. Various MRI imaging methods have been applied to neurological diseases, for example, subcortical structural changes in the substantia nigra, striatum and subthalamic nucleus have been noted in Parkinson's disease-related disorders, and structural changes in the hippocampus have been noted in Alzheimer's disease. In addition to applying these diverse imaging methods to 7 Tesla MRI, the analysis of correlations with clinical symptom scales is expected to elucidate the pathophysiology, make early diagnosis and capture pathological changes over time.
The aim of this study is to assess disease-induced changes in subcortical and cortical structures such as substantia nigra, striatum, subthalamic nucleus, red nucleus and dentate nucleus in patients with neurological diseases by multimodal imaging measurements.
Basic objectives2
Others
Basic objectives -Others
The significance of this study is that, by using images with extremely high resolution compared to conventional imaging studies, it is possible to find a link between symptoms and minute structural changes that could not be clarified before, thereby providing basic knowledge for treatment and future research development.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in changes over time in T1, T2, QSM, functional connectivity, and oriented dispersion values in cortical areas and basal ganglia and deep grey matter obtained from MRI imaging in the patient group and the healthy group.
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
7T MRI
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
(i) Adults aged 18 and over.
(ii) Patients undergoing treatment in the outpatient or inpatient department of neurology at Kyoto University Hospital.
Key exclusion criteria
(i) If the patient's general condition is extremely poor (e.g. abnormal vital signs).
(ii) If the subject is judged to be unfit for MRI examination according to the attached document 'MRI examination and preliminary checklist'.
(iii) Other cases where the principal investigator deems the subject to be unsuitable as a research subject.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University
Division name
Human Health Sciences
Zip code
6068507
Address
53 Kawahara-cho Shogoin Sakyo-ku Kyoto City
TEL
0757513766
shiima@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Shima |
Organization
Kyoto University
Division name
Human Health Sciences
Zip code
606
Address
53 Kawahara-cho Shogoin Sakyo-ku Kyoto City
TEL
0757513111
Homepage URL
shiima@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Ethics committee
Address
54 kawahara-cho, Shogoin, Sakyo-ku Kyoto
Tel
0757514680
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
| 2024 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2034 | Year | 03 | 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
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062985
