UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019589