UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034230 |
|---|---|
| Receipt number | 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 | 2021/03/31 18:08:33 |
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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 | Naoto |
| Middle name | |
| Last name | Kunii |
Organization
the University of Tokyo Hospital
Division name
neurosurgery
Zip code
1138655
Address
7-3-1,hongo,bunkyo-ku,tokyo
TEL
03-3815-5411
nkunii-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takabatake |
Organization
the University of Tokyo Hospital
Division name
neurosurgery
Zip code
1138655
Address
7-3-1,hongo,bunkyo-ku,tokyo
TEL
03-3815-5411
Homepage URL
takabatake-tky@umin.ac.jp
Sponsor or person
Institute
the University of Tokyo
Institute
Department
Personal name
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
university of tokyo
Address
hongo 7-3-1,bunkyo-ku,tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 09 | Month | 21 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038973
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| Registered date | File name |
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| Registered date | File name |
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