UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039090 |
|---|---|
| Receipt number | R000044580 |
| Scientific Title | Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis |
| Date of disclosure of the study information | 2020/01/08 |
| Last modified on | 2023/01/10 11:11:14 |
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Basic information
Public title
Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis
Acronym
Effects of Brain-Machine Interface Training on Stroke Upper Extremity Paralysis
Scientific Title
Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis
Scientific Title:Acronym
Effects of Brain-Machine Interface Training on Stroke Upper Extremity Paralysis
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Brain plasticity is induced by BMI in the injured and non-injured hemispheres, and its effects and effects are examined in hemiplegic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroencephalogram change
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Repetitive motor recall training using BMI driven by EEG responses in the affected hemisphere
Interventions/Control_2
Repetitive motor recall training using BMI driven by EEG responses in the unaffected hemisphere
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 and Female
Key inclusion criteria
Hemiplegic stroke patients with unilateral cerebral hemispheric lesions
Persons who have passed more than 3 months after the onset of stroke
A person with upper limb paralysis
Cognitive and higher brain dysfunction may be present, but the purpose and method of the study can be understood.
Passive range of motion of the paretic shoulder should be 100 degrees or more.
Key exclusion criteria
Contraindications to exercise therapy
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
+81-3-5363-3832
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
+81-3-5363-3832
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2020 | Year | 01 | Month | 08 | 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
24
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
| 2019 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044580
