UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041215
Receipt number R000047071
Scientific Title The brain activities in cognitive tasks and cooperation activities.
Date of disclosure of the study information 2020/08/01
Last modified on 2021/06/12 06:26:21

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Basic information

Public title

The brain activities in cognitive tasks and cooperation activities.

Acronym

The brain activities in cognitive tasks and cooperation activities.

Scientific Title

The brain activities in cognitive tasks and cooperation activities.

Scientific Title:Acronym

The brain activities in cognitive tasks and cooperation activities.

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1. To examine the brain activity in the cognitive tasks
2. To examine the relationship between cooperation activities and cognitive and mental functions

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cerebral blood flow
Stroop task
Profile of Mood States 2nd Edition
The Two-Dimensional Mood Scale

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Effortful cognitive task

Interventions/Control_2

Effortless cognitive task

Interventions/Control_3

Face-to-face Cooperation task

Interventions/Control_4

Online cooperation task

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

Right-handed healthy adults

Key exclusion criteria

If the subjects have stroke, dementia, depression or schizophrenia diseases.
Subjects with poor vision or hearing.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Gunma University Graduate School of Health Sciences

Division name

Department of Rehabilitation Sciences

Zip code

3718514

Address

3-39-22 Showa, Maebashi, Gunma, Japan

TEL

0272208993

Email

tkenji@gunma-u.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Tsuchiya

Organization

Gunma University Graduate School of Health Sciences

Division name

Department of Rehabilitation Sciences

Zip code

3718514

Address

3-39-22 Showa, Maebashi, Gunma, Japan

TEL

0272208993

Homepage URL


Email

tkenji@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Gunma University

Address

3-39-15 Showa, Maebashi, Gunma, Japan

Tel

0275528740

Email

hitotaisho-ciru@ml.gunma-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

2020 Year 08 Month 01 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 07 Month 27 Day

Date of IRB


Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2023 Year 02 Month 28 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 07 Month 27 Day

Last modified on

2021 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name