UMIN-CTR Clinical Trial

Basic information
Public title	An MEG study regarding the relationship between magnetic neural activity and fatigue sensation
Acronym	An MEG study regarding the relationship between magnetic neural activity and fatigue sensation
Scientific Title	An MEG study regarding the relationship between magnetic neural activity and fatigue sensation
Scientific Title:Acronym	An MEG study regarding the relationship between magnetic neural activity and fatigue sensation
Region	Japan

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

Objectives
Narrative objectives1	To clarify the relationship between magnetic neural activity and fatigue sensation
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	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

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 Akira Middle name Last name Ishii
Organization	Osaka City University Graduate School of Medicine
Division name	Sports medicine
Zip code	545-8585
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 Akira Middle name Last name Ishii
Organization	Osaka City University Graduate School of Medicine
Division name	Sports medicine
Zip code	545-8585
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	Japan Science and Technology Agency
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	The Ethics Committee of Osaka City University Graduate School of Medicine
Address	1-2-7, Asahi-machi, Abeno-ku, Osaka, 545-8533
Tel	06-6645-3435
Email	ethics@med.osaka-cu.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	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	2019 Year 03 Month 11 Day

Related information
URL releasing protocol	https://physoc.onlinelibrary.wiley.com/doi/full/10.14814/phy2.15028
Publication of results	Published

Result
URL related to results and publications	https://physoc.onlinelibrary.wiley.com/doi/full/10.14814/phy2.15028
Number of participants that the trial has enrolled	26
Results	Electromagnetic cortical neuronal activity while performing cognitive tasks was associated with a decrease in motivation caused by the tasks.
Results date posted	2022 Year 08 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 09 Month 23 Day
Baseline Characteristics	Healthy volunteers
Participant flow	Twenty-six volunteers participated in this study and the data from 10 participants were excluded from the analyses because of software issues, the contamination of the MEG data with magnetic artifacts, and the failure in empty room recording as a baseline MEG data (i.e., the data from 16 participants were analyzed).
Adverse events	None
Outcome measures	Total amount of electromagnetic neural activity
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 02 Month 28 Day
Date of IRB	2019 Year 01 Month 24 Day
Anticipated trial start date	2019 Year 04 Month 22 Day
Last follow-up date	2021 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	2019 Year 02 Month 18 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040919