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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024679
Receipt No. R000028396
Scientific Title Examination of the effect of neurofeedback on cognitive functions
Date of disclosure of the study information 2016/11/03
Last modified on 2019/05/08

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Basic information
Public title Examination of the effect of neurofeedback on cognitive functions
Acronym Examination of the effect of neurofeedback on cognitive functions
Scientific Title Examination of the effect of neurofeedback on cognitive functions
Scientific Title:Acronym Examination of the effect of neurofeedback on cognitive functions
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of neurofeedback training on the cognitive functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation between the change of BOLD signals and the psychological changes
Key secondary outcomes

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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Day1
Psychological test: 110min
Break time
MRI scan: 45min
Break time
MRI scan: 90min

Day2
MRI scan: 90min

Day3
MRI scan: 90min

Day4
MRI scan: 90min
Break time
MRI scan: 45min
Break time
Psychological test: 25min
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
40 years-old >
Gender Male and Female
Key inclusion criteria Healthy individuals who have the ability to provide informed consent.
Key exclusion criteria Psychiatric disorders including drug dependence
Serious medical illness
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Makiko
Middle name
Last name Yamada
Organization National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Division name Department of Functional Brain Imaging Research
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 043-206-3251
Email yamada.makiko@qst.go.jp

Public contact
Name of contact person
1st name Haruki
Middle name
Last name Nishimura
Organization National Institute of Radiological Sciences
Division name Department of Functional Brain Imaging Research
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 043-206-3025
Homepage URL
Email nishimura.haruki@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
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 Certified Review Board
Address 4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel 043-206-4709
Email helsinki@qst.go.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
2016 Year 11 Month 03 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 02 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
2016 Year 11 Month 02 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028396

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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