Unique ID issued by UMIN | UMIN000026372 |
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Receipt number | R000030299 |
Scientific Title | Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval. |
Date of disclosure of the study information | 2017/03/02 |
Last modified on | 2024/03/04 16:30:12 |
Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.
The BEST-BRAIN trial
Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.
The BEST-BRAIN trial
Japan |
Severe hemiparatic stroke
Rehabilitation medicine |
Others
NO
To evaluate effectiveness and safety of an intensive rehabilitation program with the EEG-based BMI rehabilitation system for patients with severe hemiparetic stroke
Safety,Efficacy
Confirmatory
Phase II,III
Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA)
1. Sub-scales of FMA
2. Barthel Index
3. Motor Activity Log
4. Stroke Impairment Assessment Set
5. Goal Attainment Scaling
6. electromyography of finger extensor muscles
7. electroencephalography during BMI training
8. MAS
9. SS-QOL
10. ARAT
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Device,equipment |
BMI group: BMI training and conventional occupational therapy
Control group: motor imagery training and conventional occupational therapy
Control group: motor imagery training and conventional occupational therapy
18 | years-old | <= |
Not applicable |
Male and Female
1 time from stroke onset longer than 90 days
2 first ever stroke patients satisfied all criteria indicated below
a. proprioceptive sensory score on SIAS is more than 1
b knee-mouth test sore on SIAS is more than 2
c passive range of motion is minus 10 degrees for metacarpophalangeal joint extension
d finger test score on SIAS is 1A
3 ability to walk independently in daily life with or without assistance
4 ability to understand and consent the study protocol by himself
1.serious medical conditions for rehabilitation indicated below
a. severe heart disease
b. uncontrolled hypertension
c. history of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment
d. severe hepatic or renal dysfunction
e. severe orthopedic impairment
f. severe cognitive or psychiatric disorder
g. other serious medical conditions
2. pacemaker or other implanted stimulator use
3. history of seizures within 90 days before enrollment
4. participation of other clinical trial for regulatory approval within 90 days before enrollment
5.receiving other special neurorehabilitation technique for upper extremity paresis, such as trans cranial magnetic stimulation, therapeutic electrical stimulation, constraint induced movement therapy, and repetitive facilitative exercise, within 90 days before enrollment
6. injection of botulinum toxin or phenol for treatment of upper limb spasticity within 90 days before enrollment
7. impossible to record electroencephalography because of skin status or skull deformity
8. other critical problems to participate the study
40
1st name | Katsuhiro |
Middle name | |
Last name | Mizuno |
Keio University Hospital
Department of rehabilitation medicine
160-8582
35, Shinanomachi, Shinjukuku, Tokyo
03-3353-1211
mizuno-k@keio.jp
1st name | Kimiko |
Middle name | |
Last name | Tsuchiya |
Keio University Hospital
Department of rehabilitation medicine
160-8582
35, Shinanomachi, Shinjukuku, Tokyo
03-5363-3833
ktsuchiya@keio.jp
Department of rehabilitation medicine,Keio University Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
Keio University Hospital Institutional Review Board
35, Shinanomachi, Shinjukuku, Tokyo
03-3353-1211
-
NO
慶應義塾大学病院(東京都)
済生会神奈川県病院(神奈川県)
東京湾岸リハビリテーション病院(千葉)
東京都リハビリテーション病院(東京)
2017 | Year | 03 | Month | 02 | Day |
Unpublished
Completed
2016 | Year | 12 | Month | 27 | Day |
2016 | Year | 12 | Month | 27 | Day |
2017 | Year | 03 | Month | 03 | Day |
2018 | Year | 10 | Month | 31 | Day |
2017 | Year | 03 | Month | 02 | Day |
2024 | Year | 03 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030299
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