UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018558 |
|---|---|
| Receipt number | R000021473 |
| Scientific Title | Effect of subacute fatigue on the central nervous system |
| Date of disclosure of the study information | 2015/08/06 |
| Last modified on | 2018/08/09 08:50:53 |
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Basic information
Public title
Effect of subacute fatigue on the central nervous system
Acronym
Effect of subacute fatigue on the central nervous system
Scientific Title
Effect of subacute fatigue on the central nervous system
Scientific Title:Acronym
Effect of subacute fatigue on the central nervous system
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 subacute 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
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Physical fatigue load, MEG, head 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
Key exclusion criteria
Participants with past or current history of serious medical illness and/or brain organic disease, who take central nervous system acting drugs, who are contradicted to the use of MRI, or 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
Department of Physiology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585
TEL
06-6645-3711
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
Department of Physiology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585
TEL
06-6645-3711
Homepage URL
masa-t@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT) 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
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 | 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
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021473
