UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034594 |
|---|---|
| Receipt number | R000039442 |
| Scientific Title | Benefits of neuro-feedback-cognitive training using NIRS on cognitive function |
| Date of disclosure of the study information | 2018/10/22 |
| Last modified on | 2025/10/27 09:04:04 |
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Basic information
Public title
Benefits of neuro-feedback-cognitive training using NIRS on cognitive function
Acronym
Benefits of neuro-feedback-cognitive training
Scientific Title
Benefits of neuro-feedback-cognitive training using NIRS on cognitive function
Scientific Title:Acronym
Benefits of neuro-feedback-cognitive training
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the benefit of neuro-feedback cognitive training on cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of processing speed test
Key secondary outcomes
Cognitive function(FAB, stroop, verbal fluency, Raven, JART, Logical memory, digit span, D-CAT, symbol search, digit symbol coding, mental rotation)
Brain activation by NIRS
Mental health(STAI, WHO-5, GHQ12: General Health Questionnaire 12, POMS, CES-D, daily habits, effortful control)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
cognitive training with neuro-feedback (20 minutes game, everyday per week for 6 weeks)
Interventions/Control_2
cognitive training without neuro-feedback (20 minutes game, everyday per week for 6 weeks)
Interventions/Control_3
active control(20 minutes game, everyday per week for 6 weeks)
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
right handed Japanese young adults who play video game less than 1 hour per week past 2 years
Key exclusion criteria
We will exclude the subjects with mental disorder, diabetes, cranial nerve disease, cardiac disease.
The subject participated in other intervention study within 2 months.
The subject can not write the game diary everyday and can not take pre- and post- assessments.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | Nouchi |
Organization
Tohoku University
Division name
SARC
Zip code
980-8575
Address
Sendai, seiryo-machi 4-1
TEL
022-717-8952
rui.nouchi.a4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Nouchi |
Organization
Tohoku Univeristy
Division name
SARC
Zip code
985-8575
Address
Sendai, seiryo-machi 4-1
TEL
022-717-8952
Homepage URL
rui.nouchi.a4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
NeU
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicin
Address
Seiryo2-1, Sendai, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2018 | Year | 10 | Month | 22 | 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
| 2018 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039442
