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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018559
Receipt No. R000021476
Scientific Title Effect of mental fatigue on facilitation and inhibition systems
Date of disclosure of the study information 2015/08/06
Last modified on 2018/08/09

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Basic information
Public title Effect of mental fatigue on facilitation and inhibition systems
Acronym Effect of mental fatigue on facilitation and inhibition systems
Scientific Title Effect of mental fatigue on facilitation and inhibition systems
Scientific Title:Acronym Effect of mental fatigue on facilitation and inhibition systems
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the neural mechanisms of facilitation and inhibition systems under the condition of mental fatigue using MEG
Basic objectives2 Others
Basic objectives -Others To clarify the neural mechanisms of fatigue
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MEG data
Key secondary outcomes Questionnaires

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Cognitive task, MEG, structural MRI, and questionnaires
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
65 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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Physiology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL 06-6645-3711
Email masa-t@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Physiology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL 06-6645-3711
Homepage URL
Email masa-t@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 06 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 Completed
Date of protocol fixation
2015 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 06 Day
Last follow-up date
2018 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
2015 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021476

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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