UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016878 |
|---|---|
| Receipt number | 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 | 2022/09/27 10:06:07 |
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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
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
tokadat@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
https://hbrc.med.kyoto-u.ac.jp/?page_id=472
Publication of results
Unpublished
Result
URL related to results and publications
https://hbrc.med.kyoto-u.ac.jp/?page_id=472
Number of participants that the trial has enrolled
8
Results
To observe neuronal degeneration, T2star-weihted imaging, quantitative suscpetibility mapping and NODDI(neurite orientation dispersion and density index) measurements were conducted in 4 ALS patients and 4 control subjects.
As a result, NODDI measurement showed decrease of neurite density in the primary motor area. However, due to changes in collaborators, this research could not be continued and quitted.
Results date posted
| 2022 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Limited enrollment.
Participant flow
Patients and subjects were recruited inside of the university and enrolled after obtaining written informed consents.
Adverse events
None.
Outcome measures
Statistically significant difference in MRI derived values.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
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
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019589
