UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035373
Receipt number R000040306
Scientific Title Research of the activation pattern change of brain by motor learning utilizing diffusion MRI and functional MRI and application to neural plasticity
Date of disclosure of the study information 2018/12/27
Last modified on 2018/12/26 19:40:57

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Basic information

Public title

Research of the activation pattern change of brain by motor learning utilizing diffusion MRI and functional MRI and application to neural plasticity

Acronym

Research of the activation pattern change of brain by motor learning utilizing diffusion MRI and functional MRI and application to neural plasticity

Scientific Title

Research of the activation pattern change of brain by motor learning utilizing diffusion MRI and functional MRI and application to neural plasticity

Scientific Title:Acronym

Research of the activation pattern change of brain by motor learning utilizing diffusion MRI and functional MRI and application to neural plasticity

Region

Japan


Condition

Condition

Neurodegenerative disease, Stroke

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Research of the activation pattern change of brain by motor learning and application to neural plasticity

Basic objectives2

Others

Basic objectives -Others

not applicable

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pattern discovery of brain activation pattern by motor learning and application to neural plasticity

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

MRI

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

35 years-old >=

Gender

Male and Female

Key inclusion criteria

Athletes with a winning record at sports competitions
Other, general youth

Key exclusion criteria

Person who has a history of intracranial disease or neurosurgical operation. Persons undergoing treatment for mental disease, epilepsy, etc. Person who had a history of surgical implantation of metal in the body, which impedes MRI, person with claustrophobia, a person with a history of traumatic lesions in the skull.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenori Sugano

Organization

Juntendo University

Division name

Department of neurosurgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

debo@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takumi Mitsuhashi

Organization

Juntendo University

Division name

Department of neurosurgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

tmituha@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Japan science and technology agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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 27 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

Open public recruiting

Date of protocol fixation

2018 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 23 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 26 Day

Last modified on

2018 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name