UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054169 |
|---|---|
| Receipt number | R000061857 |
| Scientific Title | Brain mechanisms in operating the brain-computer interface |
| Date of disclosure of the study information | 2024/04/18 |
| Last modified on | 2024/04/17 16:24:24 |
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Basic information
Public title
Brain mechanisms in operating the brain-computer interface
Acronym
Brain mechanisms in operating the brain-computer interface
Scientific Title
Brain mechanisms in operating the brain-computer interface
Scientific Title:Acronym
Brain mechanisms in operating the brain-computer interface
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the brain mechanisms in operating the brain-computer interface
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire answers
Decision-Making Task responses
Dominant hand test results
KVIQ (kinematic imagery) answers
Personality trait answers
Brain image measured by MRI
Results of EEG BCI task during MRI measurement
Results of EEG BCI Task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
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 study will involve training the EEG brain-computer interface for 2 to 6 days and comparing MRI brain images and EEG signals before and after training.
Interventions/Control_2
The study will test if applying a weak vibration to the wrist as feedback after the success or failure of the EEG brain-computer interface operation improves performance.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who can provide free and voluntary written consent to participate in the research, and do not meet the exclusion criteria.
Key exclusion criteria
Women who are pregnant or may become pregnant.
Persons suffering from higher brain dysfunction or mental illness.
Persons with visual impairment.
Persons who have difficulty in walking.
Persons with a history of cerebrovascular disease or circulatory disease
Persons with metal, equipment, or artificial objects in the body
Persons with tattoos
Persons with claustrophobia
Persons weighing 100 kg or more
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kazumi |
| Middle name | |
| Last name | Kasahara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba City, Ibaraki
TEL
050-3522-4975
k.kasahara@aist.go.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Kasahara |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
1-1-1 Higashi, Tsukuba City, Ibaraki
TEL
050-3522-4975
Homepage URL
k.kasahara@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology (AIST) Committee on Bioethics
Address
1-1-1 Higashi, Tsukuba City, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.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
| 2024 | Year | 04 | Month | 18 | 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
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
