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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002006
Receipt No. R000002443
Scientific Title Brain-Machine Interface for hand paralysis in patients with chronic-phase stroke
Date of disclosure of the study information 2009/05/28
Last modified on 2019/03/06

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Basic information
Public title Brain-Machine Interface for hand paralysis in patients with chronic-phase stroke
Acronym Brain-Machine Interface for hand paralysis in patients with chronic-phase stroke
Scientific Title Brain-Machine Interface for hand paralysis in patients with chronic-phase stroke
Scientific Title:Acronym Brain-Machine Interface for hand paralysis in patients with chronic-phase stroke
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to examine the feasibility of operating a mechanical hand orthosis with motor imagery interfaced with non-invasive electroencephalogram (EEG)-based Brain-Machine Interface (BMI) for paralyzed upper extremity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degrees of event-related desynchronization (ERD) , Mean classification accuracy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Motor imagery of the affected hand with electroencephalogram-based Brain Machine Interface.
Interventions/Control_2
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 First Attack of Stroke, Affected finger paresis is lower than 2 classified by Stroke Impairment Assessment Set.
Key exclusion criteria Episode of epilepsy, Cogniive Deficits difficult to understand the study, Metalic something in body.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiichiro Shindo
Organization Tokyo Metropolitan Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
Address 2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Metropolitan Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
Address
TEL
Homepage URL
Email kshindo@tokyo-reha.jp

Sponsor
Institute Tokyo Metropolitan Rehabilitation Hospital
Institute
Department

Funding Source
Organization Strategic Research Program for Brain Sciences (SRPBS) of Ministry of Education, Culture, Sports, Science and Technology, Japan.
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.medicaljournals.se/jrm/content/abstract/10.2340/16501977-0859
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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 25 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002443

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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