UMIN-CTR Clinical Trial

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	Adult
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	The responses and the reaction times during cognitive-bias tasks. The Questionnaires about the subjective experiences of emotion.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	pgACC Feedback Group Day1 Informed Consent: 30min MRI scan: 70min Break time: 15min Psychological test: 120min Day2 MRI scan: 70min Break time: 15min Psychological test: 60min Day3 - Day6 MRI scan: 90min Day7 MRI scan: 70min Break time: 15min Psychological test: 60min
Interventions/Control_2	IPS Feedback Group Day1 Informed Consent: 30min MRI scan: 70min Break time: 15min Psychological test: 120min Day2 MRI scan: 70min Break time: 15min Psychological test: 60min Day3 - Day6 MRI scan: 90min Day7 MRI scan: 70min Break time: 15min Psychological test: 60min
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	1. Healthy individuals who have the ability to provide informed consent. 2. Right-handed persons.
Key exclusion criteria	1. Psychiatric disorders including drug dependence and serious medical illness. 2. Parsons with suspected abnormal findings (such as obvious cerebral infarction, cerebral hemorrhage, etc.) in MRI examination. 3. Persons with pacemakers, internal metal (brain clips, bolts, orthodontic appliances, etc.). 4. Persons who have tattoos (including tattoos and art makeup). 5. Persons who are claustrophobia.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Makiko Middle name Last name Yamada
Organization	National Institutes for Quantum Science and Technology Quantum Life and Medical Science Directorate Institute for Quantum Medical Science
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 Yasunori Middle name Last name Aizawa
Organization	National Institutes for Quantum Science and Technology Institute for Quantum Medical Science
Division name	Department of Functional Brain Imaging Research
Zip code	263-8555
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	043-206-3249
Homepage URL
Email	aizawa.yasunori@qst.go.jp

Sponsor
Institute	National Institutes for Quantum Science and Technology Quantum Life and Medical Science Directorate Institute for Quantum Medical Science
Institute
Department

Funding Source
Organization	National Institutes for Quantum Science and Technology Quantum Life and Medical Science Directorate Institute for Quantum Medical Science
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	Completed
Date of protocol fixation	2016 Year 10 Month 28 Day
Date of IRB	2016 Year 10 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 02 Day
Last follow-up date	2021 Year 04 Month 27 Day
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	2022 Year 11 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028396