UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037063 |
|---|---|
| Receipt number | 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 16:30:29 |
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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
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
tyanagisawa@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042229
