UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039090
Receipt No. 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 2020/01/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.