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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035234
Receipt No. 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 2018/12/12

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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
Middle name
Last name Nobukatsu Sawamoto
Organization Kyoto University Graduate School of Medicine
Division name Human Health Sciences
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL 075-751-3111
Email sawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Shima
Organization Kyoto University Graduate School of Medicine
Division name Neurology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL 075-751-3111
Homepage URL
Email shiima@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 12 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040147

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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