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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028980
Receipt No. 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

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

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
URL(English) https://upload.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


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