UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Title of the study (Brief title)	Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Region	Japan

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

Objectives
Narrative objectives1	To investigate how types of neurofeedback using BMI effect on brain activity and structure as measured with VBM and rsfMRI. To investigate relationships between motor paresis and these effects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	VBM rsfMRI
Key secondary outcomes	ERD motor performance

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	A motor orthosis is driven by ERD
Interventions/Control_2	A motor orthosis is always driven independent with ERD
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	1) more than 2 months from the first stroke onset (except for SAH), 2) age from 20 to 80, 3) no severe cognitive function (MMSE >23), 4) no metal preventing MRI scanning, 5) no medication such as anticonvulsants, antidepression, 5) no severe comorbidity.
Key exclusion criteria	above
Target sample size	20

Research contact person
Name of lead principal investigator	Keiichiro Shindo
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Rehabilitation Medicine
Address	2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL	03-3616-8600
Email	krugreims@yahoo.co.jp

Public contact
Name of contact person	Keiichiro Shindo
Organization	Tokyo Metropolitan Rehabilitation Hospital
Division name	Rehabilitation Medicine
Address	2-14-1, Tsutsumi do-ri, Sumida-ku, Tokyo
TEL	03-3616-8600
Homepage URL	http://www.keio-reha.com/index.html
Email	krugreims@yahoo.co.jp

Sponsor
Institute	Keio University, Department of Rehabilitation Medicine
Institute
Department

Funding Source
Organization	Strategic Research Program for Brain Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京都リハビリテーション病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 22 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019987