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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034230
Receipt No. R000038973
Scientific Title A study on neurofeedback using scalp electroencephalography of healthy people
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/21

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Basic information
Public title A study on neurofeedback using scalp electroencephalography of healthy people
Acronym EEG neurofeedback study
Scientific Title A study on neurofeedback using scalp electroencephalography of healthy people
Scientific Title:Acronym EEG neurofeedback study
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the correlation between EEG change by neurofeedback and the alteration of cognitive function.
Basic objectives2 Others
Basic objectives -Others To investigate the change of alpha wave power modulated by neurofeedback.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electroencephalography findings altered by neurofeedback and results of cognitive function evaluation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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
Other
Interventions/Control_1 the group which is provided with auditory neurofeedback of alpha wave power in the former part and shame-random feedback in the latter part
Interventions/Control_2 the group which is provided with shame-random feedbackin the former part and auditory neurofeedback of alpha wave power in the latter part
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 To have normal cognitive function.
Key exclusion criteria To have a medical history of psychiatric or neurological disorders.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Kunii
Organization the University of Tokyo Hospital
Division name neurosurgery
Zip code
Address 7-3-1,hongo,bunkyo-ku,tokyo
TEL 03-3815-5411
Email nkunii-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Takabatake
Organization the University of Tokyo Hospital
Division name neurosurgery
Zip code
Address 7-3-1,hongo,bunkyo-ku,tokyo
TEL 03-3815-5411
Homepage URL
Email takabatake-tky@umin.ac.jp

Sponsor
Institute the University of Tokyo
Institute
Department

Funding Source
Organization the University of Tokyo
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
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 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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 09 Month 21 Day
Last modified on
2018 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038973

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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