UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028980
Receipt number R000032134
Scientific Title An MEG study regarding the effect of fatigue sensation on decision making
Date of disclosure of the study information 2017/09/11
Last modified on 2020/03/09 09:23:11

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Basic information

Public title

An MEG study regarding the effect of fatigue sensation on decision making

Acronym

An MEG study regarding the effect of fatigue sensation on decision making

Scientific Title

An MEG study regarding the effect of fatigue sensation on decision making

Scientific Title:Acronym

An MEG study regarding the effect of fatigue sensation on decision making

Region

Japan


Condition

Condition

Healthy

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of the fatigue sensation on decision making

Basic objectives2

Others

Basic objectives -Others

To investigate the neural mechanisms of fatigue sensation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The MEG data

Key secondary outcomes

Questionnaires


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Cognitive task 1, cognitive task 2, cognitive task 3

Interventions/Control_2

Cognitive task 1, cognitive task 3, cognitive task 2

Interventions/Control_3

Cognitive task 2, cognitive task 1, cognitive task 3

Interventions/Control_4

Cognitive task 2, cognitive task 3, cognitive task 1

Interventions/Control_5

Cognitive task 3, cognitive task 1, cognitive task 2

Interventions/Control_6

Cognitive task 3, cognitive task 2, cognitive task 1

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult

Key exclusion criteria

Participants with past or current history of serious medical illness and/or brain organic disease, who take central nerve system acting drugs, who are contradicted for the use of MRI, and who are judged as not suitable for participation in this study.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Ishii

Organization

Osaka City University Graduate School of Medicine

Division name

Sports medicine

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585

TEL

06-6645-3790

Email

a.ishii@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Ishii

Organization

Osaka City University Graduate School of Medicine

Division name

Sports medicine

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585

TEL

06-6645-3790

Homepage URL


Email

a.ishii@med.osaka-cu.ac.jp


Sponsor or person

Institute

Department of Sports Medicine, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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


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

大阪市立大学医学部附属病院(大阪)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 11 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

Main results already published

Date of protocol fixation

2017 Year 06 Month 26 Day

Date of IRB

2017 Year 06 Month 26 Day

Anticipated trial start date

2017 Year 07 Month 11 Day

Last follow-up date

2019 Year 09 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 04 Day

Last modified on

2020 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name