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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016878
Receipt No. R000019589
Scientific Title Integrated axonal fiber tracking and functional MR imaging study of brain and spinal cord for neurodegenerative disorders
Date of disclosure of the study information 2015/03/24
Last modified on 2019/03/25

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Basic information
Public title Integrated axonal fiber tracking and functional MR imaging study of brain and spinal cord for neurodegenerative disorders
Acronym Integrated axonal fiber tracking and functional MR imaging study for neurodegenerative disorders
Scientific Title Integrated axonal fiber tracking and functional MR imaging study of brain and spinal cord for neurodegenerative disorders
Scientific Title:Acronym Integrated axonal fiber tracking and functional MR imaging study for neurodegenerative disorders
Region
Japan

Condition
Condition neurodegenerative disease, epilepsy, etc.
Classification by specialty
Neurology Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To perform magnetic resonance (MR) neural axons structural imaging, brain functional imaging and blood flow imaging as well as MR anatomical images in healthy subjects and patients with neurodegenerative disorders, and to establish a comprehensive imaging evaluation associated with pathophysiology.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain MR imaging, scales for the objective assessment
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1. Healthy subjects at the age over 20, with no history of neurological and psychiatric disorder who agree the purpose and procedure of the study with the paper agreement form.

2. Neurological disorder patients who are diagnosed as neurodegenerative disease at the neurological department of Kyoto University Hospital. Among admitted inpatients and periodically followed up outpatients, those who agree the purpose and procedure of the study with the paper agreement form.
Key exclusion criteria Subjects who have difficulty in acquiring MRI revealed by a MRI questionnaire
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Togashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Diagnostic Imaging and Nuclear Medicine
Zip code 6068507
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3760
Email nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Tsutomu
Middle name
Last name Okada
Organization Kyoto University Hospital
Division name Department of Diagnostic Radiology
Zip code 6068507
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3760
Homepage URL
Email tokadat@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
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 Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
Tel 075-751-3760
Email tokadat@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
2015 Year 03 Month 24 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
2015 Year 03 Month 24 Day
Date of IRB
2015 Year 09 Month 03 Day
Anticipated trial start date
2015 Year 09 Month 03 Day
Last follow-up date
2019 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-shell diffusion imaging for NODDI analysis were obtained. Diffusion tensor and Q-ball imaging analysis, fiber tracking from these two dataset were performed

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019589

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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