UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040540
Receipt number R000046275
Scientific Title Longitudinal MRI study on acquisition of novel categories
Date of disclosure of the study information 2020/05/27
Last modified on 2023/05/31 10:36:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Category Acquisition MRI study

Acronym

Category Acquisition

Scientific Title

Longitudinal MRI study on acquisition of novel categories

Scientific Title:Acronym

Category Acquisition

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to uncover longitudinal changes of neural systems underlying novel visual category acquisition

Basic objectives2

Others

Basic objectives -Others

Observation study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship among task fMRI, structural MRI, diffusion MRI, quantitative MRI, MRS, and behavioral scores (visual cognition, learning, and memory)

Key secondary outcomes

Relationship between personality and MRI signals


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Learning a foreign language

Interventions/Control_2

Learning a foreign language

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

Their mother language should be Japanese.

Key exclusion criteria

Psychiatric disorders including drug dependence
Serious medical illness

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Makiko
Middle name
Last name Yamada

Organization

National Institutes for Quantum Science and Technology

Division name

Institute of Quantum Medical Science

Zip code

263-8555

Address

4-9-1 Anagawa, Inage, Chiba

TEL

043-206-3249

Email

yamada.makiko@qst.go.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Matsuyoshi

Organization

National Institutes for Quantum Science and Technology

Division name

Institute of Quantum Medical Science

Zip code

263-8555

Address

4-9-1 Anagawa, Inage, Chiba

TEL

043-206-3249

Homepage URL


Email

matsuyoshi.daisuke@qst.go.jp


Sponsor or person

Institute

National Institutes for Quantum Science and Technology

Institute

Department

Personal name



Funding Source

Organization

JSPS/MEXT

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

Institutional Review Board at QST

Address

4-9-1 Anagawa, Inage, Chiba

Tel

043-206-4709

Email

helsinki@qst.go.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

国立研究開発法人量子科学技術研究開発機構(千葉県)


Other administrative information

Date of disclosure of the study information

2020 Year 05 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

Preinitiation

Date of protocol fixation

2020 Year 04 Month 03 Day

Date of IRB

2020 Year 04 Month 03 Day

Anticipated trial start date

2023 Year 08 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 27 Day

Last modified on

2023 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046275


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name