UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039090
Receipt number R000044580
Scientific Title Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis
Date of disclosure of the study information 2020/01/08
Last modified on 2023/01/10 11:11:14

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Basic information

Public title

Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis

Acronym

Effects of Brain-Machine Interface Training on Stroke Upper Extremity Paralysis

Scientific Title

Effects of Motor Image Training Using a Brain-Machine Interface on Stroke Upper Extremity Paralysis

Scientific Title:Acronym

Effects of Brain-Machine Interface Training on Stroke Upper Extremity Paralysis

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Brain plasticity is induced by BMI in the injured and non-injured hemispheres, and its effects and effects are examined in hemiplegic stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

electroencephalogram change

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Repetitive motor recall training using BMI driven by EEG responses in the affected hemisphere

Interventions/Control_2

Repetitive motor recall training using BMI driven by EEG responses in the unaffected hemisphere

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Hemiplegic stroke patients with unilateral cerebral hemispheric lesions
Persons who have passed more than 3 months after the onset of stroke
A person with upper limb paralysis
Cognitive and higher brain dysfunction may be present, but the purpose and method of the study can be understood.
Passive range of motion of the paretic shoulder should be 100 degrees or more.

Key exclusion criteria

Contraindications to exercise therapy

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Michiyuki
Middle name
Last name Kawakami

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku, Tokyo

TEL

+81-3-5363-3832

Email

michiyukikawakami@hotmail.com


Public contact

Name of contact person

1st name Michiyuki
Middle name
Last name Kawakami

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku, Tokyo

TEL

+81-3-5363-3832

Homepage URL


Email

michiyukikawakami@hotmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

AMED

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

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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

2020 Year 01 Month 08 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

24

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

No longer recruiting

Date of protocol fixation

2019 Year 11 Month 29 Day

Date of IRB

2019 Year 11 Month 25 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 01 Month 08 Day

Last modified on

2023 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044580


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name