UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 03 Month 26 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2019 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	2019 Year 02 Month 25 Day
Last modified on	2022 Year 01 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041009