UMIN-CTR Clinical Trial

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
Email	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
Email	michiyukikawakami@hotmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
Email	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
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 11 Month 29 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2021 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	2020 Year 01 Month 08 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044580

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.