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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037063
Receipt No. R000042229
Scientific Title Development of neurofeedback using EEG and MEG
Date of disclosure of the study information 2019/08/01
Last modified on 2019/12/14

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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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