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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | healthy subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |