UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035234 |
|---|---|
| Receipt number | R000040147 |
| Scientific Title | Elucidation of pathomechanisms of neurodegenerative diseases by 7 Tesla MRI |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2021/12/14 11:23:18 |
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Basic information
Public title
Elucidation of pathomechanisms of neurodegenerative diseases by 7 Tesla MRI
Acronym
Elucidation of pathomechanisms of neurodegenerative diseases by 7 Tesla MRI
Scientific Title
Elucidation of pathomechanisms of neurodegenerative diseases by 7 Tesla MRI
Scientific Title:Acronym
Elucidation of pathomechanisms of neurodegenerative diseases by 7 Tesla MRI
Region
| Japan |
Condition
Condition
Parkinson's disease
Alzheimer's disease
Tauopathy
Spinocerebellar degeneration
REM sleep behavior disorder
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We plan to elucidate the changes of cortical and subcortical grey matters in neurodegenerative disorders by 7T MRI.
Basic objectives2
Others
Basic objectives -Others
To elucidate the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes detected by MRI in neurodegenerative disorders
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
Obtain images in every 2 years within 4 years.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who agreed to participate in the study.
Key exclusion criteria
Patients with poor general condition and contraindication for MRI.
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Health Sciences
Zip code
6068507
Address
53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
0757513111
sawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Shima |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
6068507
Address
54 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
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida-konoe-cho, Sakyo-ku, Kyoto
Tel
0757513111075-753-4680
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
| 2018 | Year | 12 | Month | 13 | 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
| 2018 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
| 2028 | Year | 12 | Month | 11 | Day |
Date trial data considered complete
| 2028 | Year | 12 | Month | 11 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040147
