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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034594
Receipt No. 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 2018/10/22

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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
Middle name
Last name Rui Nouchi
Organization Tohoku University
Division name SARC
Zip code
Address Sendai, seiryo-machi 4-1
TEL 022-717-8952
Email rui.nouchi.a4@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rui Nouchi
Organization Tohoku Univeristy
Division name SARC
Zip code
Address Sendai, seiryo-machi 4-1
TEL 022-717-8952
Homepage URL
Email rui.nouchi.a4@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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