UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An MEG study regarding the neural mechanisms of assessing the future level of fatigue.
Title of the study (Brief title)	An MEG study regarding the neural mechanisms of assessing the future level of fatigue.
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 assessing the future level of fatigue.
Basic objectives2	Others
Basic objectives -Others	To investigate the neural mechanisms of fatigue
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The MEG data
Key secondary outcomes	Questionnaires

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Cognitive task 1, Cognitive task 2
Interventions/Control_2	Cognitive task 2, Cognitive task 1
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masaaki Tanaka
Organization	Osaka City University Graduate School of Medicine
Division name	Physiology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3711
Email	m5914885@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person	Akira Ishii
Organization	Osaka City University Graduate School of Medicine
Division name	Physiology
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka, 545-8585
TEL	06-6645-3711
Homepage URL
Email	a.ishii@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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）, Osaka City University Hospital (Osaka)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 20 Day
Anticipated trial start date	2015 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 02 Day
Last modified on	2016 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021041