UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041215 |
|---|---|
| Receipt number | R000047071 |
| Scientific Title | The brain activities in cognitive tasks and cooperation activities. |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2021/06/12 06:26:21 |
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Basic information
Public title
The brain activities in cognitive tasks and cooperation activities.
Acronym
The brain activities in cognitive tasks and cooperation activities.
Scientific Title
The brain activities in cognitive tasks and cooperation activities.
Scientific Title:Acronym
The brain activities in cognitive tasks and cooperation activities.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine the brain activity in the cognitive tasks
2. To examine the relationship between cooperation activities and cognitive and mental functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow
Stroop task
Profile of Mood States 2nd Edition
The Two-Dimensional Mood Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Effortful cognitive task
Interventions/Control_2
Effortless cognitive task
Interventions/Control_3
Face-to-face Cooperation task
Interventions/Control_4
Online cooperation task
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy adults
Key exclusion criteria
If the subjects have stroke, dementia, depression or schizophrenia diseases.
Subjects with poor vision or hearing.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchiya |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
3718514
Address
3-39-22 Showa, Maebashi, Gunma, Japan
TEL
0272208993
tkenji@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchiya |
Organization
Gunma University Graduate School of Health Sciences
Division name
Department of Rehabilitation Sciences
Zip code
3718514
Address
3-39-22 Showa, Maebashi, Gunma, Japan
TEL
0272208993
Homepage URL
tkenji@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Gunma University
Address
3-39-15 Showa, Maebashi, Gunma, Japan
Tel
0275528740
hitotaisho-ciru@ml.gunma-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | 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
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047071
