UMIN-CTR Clinical Trial

Basic information
Public title	Development of neurofeedback using EEG and MEG
Acronym	E/MEG Neurofeedbck
Scientific Title	Development of neurofeedback using EEG and MEG
Scientific Title:Acronym	E/MEG Neurofeedbck
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of neurological and cortical changes by neurofeedback training using EEG and MEG
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	neurological changes
Key secondary outcomes	changes in cortical acitivities

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	neurofeedback based on decoded information
Interventions/Control_2	neurofeedback unrelated to brain activities
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy person who can make informed consent.
Key exclusion criteria	subject who has severe neurological disfunction and whom the experimenter judged as inappropriate for the study subject who has severe diseases subject who has some implantable devices such as pace maker women who is pregnant or possible to be pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takufumi Middle name Last name Yanagisawa
Organization	Osaka University
Division name	Institute for Advanced Co-creation Studies
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	0668793652
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takufumi Middle name Last name Yanagisawa
Organization	Osaka University
Division name	Institute for Advanced Co-creation studies
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	0668793652
Homepage URL
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate school of Medicine
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University
Address	2-2 Yamadaoka, Suita, Osaka
Tel	0662108296
Email	rinri@hp-crc.med.osaka-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	2019 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	Enrolling by invitation
Date of protocol fixation	2019 Year 06 Month 13 Day
Date of IRB	2014 Year 03 Month 13 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 13 Day
Last modified on	2019 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042229

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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