UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017233
Receipt number R000019987
Scientific Title Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke
Date of disclosure of the study information 2015/04/22
Last modified on 2018/01/04 12:18:16

* 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 neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke

Acronym

Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke

Scientific Title

Effects of neurofeedback training with an electroencephalogram-based brain-computer interface for hand paralysis with stroke

Scientific Title:Acronym

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

1st name
Middle name
Last name Keiichiro Shindo

Organization

Tokyo Metropolitan Rehabilitation Hospital

Division name

Rehabilitation Medicine

Zip code


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

1st name
Middle name
Last name Keiichiro Shindo

Organization

Tokyo Metropolitan Rehabilitation Hospital

Division name

Rehabilitation Medicine

Zip code


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 or person

Institute

Keio University, Department of Rehabilitation Medicine

Institute

Department

Personal name



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)



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

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


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

2015 Year 02 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name