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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036004
Receipt No. R000041009
Scientific Title Clinical research for NIRS-EEG-BMI rehabilitation for upper limb
Date of disclosure of the study information 2019/02/25
Last modified on 2019/02/25

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Basic information
Public title Clinical research for NIRS-EEG-BMI rehabilitation for upper limb
Acronym NIRS-BMI
Scientific Title Clinical research for NIRS-EEG-BMI rehabilitation for upper limb
Scientific Title:Acronym NIRS-BMI
Region
Japan

Condition
Condition hemiparesis patients due to stoke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes of function of brain, muscle and impairment of upper limbs
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intracranial blood flow by near-infrared spectroscopy(NIRS) before and after intervention
Key secondary outcomes electromyogram(EMG), electroencephalography(EEG), Fugl-Meyer Assessment (FMA) before and after intervention

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 During the training, the EEG-BMI device detect the EEG and evaluate Event-related Desyncronization (ERD), When the ERD of proper imagery detected, the device inform the proper imagery to the participants by orthosis movement and electric stimulation. This training encourage the motor learning of upper limbs.
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
120 years-old >=
Gender Male and Female
Key inclusion criteria impairment of upper limbs
Key exclusion criteria sensory loss
cognitive impairment difficult to execute training
refractory epilepsy
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Nishida
Organization Saiseikai Higashikanagawa Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
Address 1-13-10 Nishikanagawa Kanagawa-ward Yokohama Kanagawa JAPAN
TEL 045-324-3600
Email prix0616@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Nishida
Organization Saiseikai Higashikanagawa Rehabilitation Hospital
Division name Department of rehabilitation medicine
Zip code
Address 1-13-10 Nishikanagawa Kanagawa-ward Yokohama Kanagawa JAPAN
TEL 045-324-3600
Homepage URL
Email prix0616@gmail.com

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Japanese Agency for Medical Research and Development
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
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
2019 Year 02 Month 25 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041009

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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