UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035917 |
|---|---|
| Receipt number | R000040919 |
| Scientific Title | An MEG study regarding the relationship between magnetic neural activity and fatigue sensation |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2022/08/25 13:35:24 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040919
