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

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 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

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

Value
https://center6.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