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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026372
Receipt No. 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 2019/03/04

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Basic information
Public 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.
Acronym The BEST-BRAIN trial
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.
Scientific Title:Acronym The BEST-BRAIN trial
Region
Japan

Condition
Condition Severe hemiparatic stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and safety of an intensive rehabilitation program with the EEG-based BMI rehabilitation system for patients with severe hemiparetic stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 BMI group: BMI training and conventional occupational therapy
Control group: motor imagery training and conventional occupational therapy
Interventions/Control_2 Control group: motor imagery training and conventional occupational therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Mizuno
Organization Keio University Hospital
Division name Department of rehabilitation medicine
Zip code
Address 35, Shinanomachi, Shinjukuku, Tokyo
TEL 03-3353-1211
Email mizuno-k@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiko Tsuchiya
Organization Keio University Hospital
Division name Department of rehabilitation medicine
Zip code
Address 35, Shinanomachi, Shinjukuku, Tokyo
TEL 03-5363-3833
Homepage URL
Email ktsuchiya@keio.jp

Sponsor
Institute Department of rehabilitation medicine,Keio University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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
Address
Tel
Email

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 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)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 02 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 Completed
Date of protocol fixation
2016 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 02 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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