UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037585 |
|---|---|
| Receipt number | R000042843 |
| Scientific Title | development and effect verification of lower limb brain machine interface using EEG |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2019/08/02 16:20:05 |
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Basic information
Public title
development and effect verification of lower limb brain machine interface using EEG
Acronym
development and effect verification of lower limb brain machine interface using EEG
Scientific Title
development and effect verification of lower limb brain machine interface using EEG
Scientific Title:Acronym
development and effect verification of lower limb brain machine interface using EEG
Region
| Japan |
Condition
Condition
Acute and chronic stroke
(Healthy subject)
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The existence of "plasticity of the brain" has been clarified in the field of neurological rehabilitation which has developed recently in order to recover voluntary movement ability lost by cerebral apoplexy.
In order to draw out the plasticity of the brain effectively, it is important to make the motion intention and the feedback of the sensory stimulation coincide in time, that is, to move along the motion intention. However, the existing rehabilitation support equipment does not depend on the motion intention of the patient himself, and there are many cases in which the leg is moved passively. Though there are some devices which acquire the myoelectric potential and electroencephalogram to assist the movement according to the motion intention of the person, it is difficult to acquire the myoelectric potential due to the symptom of paralysis in the acute phase. The effect of Brain machine interface utilizing the electroencephalogram has been reported, but the adaptation to the lower limbs is little. Then, in this study, the brain machine interface adaptable to the leg is developed, and it aims at realizing the motion assistance along the intention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG data
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Rehabilitation
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
| Not applicable |
Gender
Male
Key inclusion criteria
Healthy person
Key exclusion criteria
1. It is difficult for normal walking.
2. Injuries that affect the movements of lower limb.
3.Pain or injury in each joint or muscle of lower limbs
4.There is a trauma in the mounting part of the device
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Ishiyama |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
169-8555
Address
3-4-1 Okubo Shinjuku-ku, Tokyo
TEL
03-5286-3376
atsushi@waseda.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ishiyama |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
169-8555
Address
3-4-1 Okubo Shinjuku-ku, Tokyo
TEL
03-5286-3376
Homepage URL
http://www.eb.waseda.ac.jp/ishiyama/
atsushi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics review committee on Research with human subjects, Waseda University
Address
1-104 Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 05 | 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
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2020 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042843
| 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 |
