UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017233 |
|---|---|
| Receipt number | R000019987 |
| Scientific Title | Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2018/01/04 12:18:16 |
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Basic information
Public title
Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Acronym
Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Scientific Title
Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Scientific Title:Acronym
Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how types of neurofeedback using BMI effect on brain activity and structure as measured with VBM and rsfMRI. To investigate relationships between motor paresis and these effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
VBM
rsfMRI
Key secondary outcomes
ERD
motor performance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
A motor orthosis is driven by ERD
Interventions/Control_2
A motor orthosis is always driven independent with ERD
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
1) more than 2 months from the first stroke onset (except for SAH), 2) age from 20 to 80, 3) no severe cognitive function (MMSE >23), 4) no metal preventing MRI scanning, 5) no medication such as anticonvulsants, antidepression, 5) no severe comorbidity.
Key exclusion criteria
above
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Shindo |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Rehabilitation Medicine
Zip code
Address
2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
03-3616-8600
krugreims@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Shindo |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Rehabilitation Medicine
Zip code
Address
2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
03-3616-8600
Homepage URL
http://www.keio-reha.com/index.html
krugreims@yahoo.co.jp
Sponsor or person
Institute
Keio University, Department of Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Strategic Research Program for Brain Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京都リハビリテーション病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 22 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019987
