UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056221 |
|---|---|
| Receipt number | R000064236 |
| Scientific Title | Changes in desynchronized electroencephalogram due to differences in the image of hand movements when wearing a Brain-Machine Interface. |
| Date of disclosure of the study information | 2024/11/21 |
| Last modified on | 2026/02/10 18:34:23 |
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Basic information
Public title
Changes in desynchronized electroencephalogram due to differences in the image of hand movements when wearing a Brain-Machine Interface.
Acronym
Changes in desynchronized electroencephalogram due to differences in the image of hand movements when wearing a Brain-Machine Interface.
Scientific Title
Changes in desynchronized electroencephalogram due to differences in the image of hand movements when wearing a Brain-Machine Interface.
Scientific Title:Acronym
Changes in desynchronized electroencephalogram due to differences in the image of hand movements when wearing a Brain-Machine Interface.
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in desynchronized EEG due to differences in motor recall methods
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Desynchronized EEG activation level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LIFESCAPES BMI (hand type) for medical use is used. ERD is measured by performing a hand extension image. On the first day, the test is performed using visual imagery, and on the second day, it is performed using kinesthetic imagery. A two-week washout period is set between the first and second days.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers without central nervous system disorders
Age: 20 years or older, 80 years or younger
Those who can provide written consent
Key exclusion criteria
Those with metal near the head (cochlear implants, magnetic clips, deep brain stimulators, vagus nerve stimulators, etc.), or a cardiac pacemaker
Those for whom it is difficult to perform BMI
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Kagoshima University
Division name
Rehabilitation Medicine
Zip code
8908520
Address
8-35-1, Sakuragaoka, Kagoshima city, Kagoshima, Japan
TEL
099-275-5339
k2764076@kadai.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Kagoshima University
Division name
Rehabilitation Medicine
Zip code
8908520
Address
8-35-1, Sakuragaoka, Kagoshima city, Kagoshima, Japan
TEL
099-275-5339
Homepage URL
k2764076@kadai.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagoshima University Sakuragaoka Area Clinical Research Ethics Committee
Address
8-35-1, Sakuragaoka, Kagoshima city, Kagoshima, Japan
Tel
0992755354
crmc@m2.kufm.kagoshima-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
| 2024 | Year | 11 | Month | 21 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | 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 | 11 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064236
