UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038855 |
|---|---|
| Receipt number | R000044310 |
| Scientific Title | An MEG study on the neural mechanisms to regulate performance in fatigue |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2019/12/12 08:37:30 |
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Basic information
Public title
An MEG study on the neural mechanisms to regulate performance in fatigue
Acronym
An MEG study on the neural mechanisms to regulate performance in fatigue
Scientific Title
An MEG study on the neural mechanisms to regulate performance in fatigue
Scientific Title:Acronym
An MEG study on the neural mechanisms to regulate performance in fatigue
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between performance and fatigue caused by motor imagery
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
Questionnaire data
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Simulation task 1, Simulation task 2, Exercise task
Interventions/Control_2
Simulation task 2, Simulation task 1, Exercise task
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
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 drugs that affect the central nervous system, who with upper limb movement disorders, who are contraindicated for the use of MRI, and who are not in good health due to some influence 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
543-0027
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
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
543-0027
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3790
Homepage URL
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
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
Osaka City University Medical Research Ethics Review Committee
Address
Abeno Medics 6F , 1-2-7 Asahicho, Abeno-ku, Osaka
Tel
06-6645-3456
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 | 12 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2022 | 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 | 12 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044310
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
