UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026372
Receipt number R000030299
Scientific Title Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.
Date of disclosure of the study information 2017/03/02
Last modified on 2024/03/04 16:30:12

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Basic information

Public title

Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.

Acronym

The BEST-BRAIN trial

Scientific Title

Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval.

Scientific Title:Acronym

The BEST-BRAIN trial

Region

Japan


Condition

Condition

Severe hemiparatic stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effectiveness and safety of an intensive rehabilitation program with the EEG-based BMI rehabilitation system for patients with severe hemiparetic stroke

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II,III


Assessment

Primary outcomes

Change between baseline and 4 weeks after the end of the therapy of Fugl-Meyer Assessment upper extremity motor score(FMA)

Key secondary outcomes

1. Sub-scales of FMA
2. Barthel Index
3. Motor Activity Log
4. Stroke Impairment Assessment Set
5. Goal Attainment Scaling
6. electromyography of finger extensor muscles
7. electroencephalography during BMI training
8. MAS
9. SS-QOL
10. ARAT


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

BMI group: BMI training and conventional occupational therapy
Control group: motor imagery training and conventional occupational therapy

Interventions/Control_2

Control group: motor imagery training and conventional occupational therapy

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 time from stroke onset longer than 90 days
2 first ever stroke patients satisfied all criteria indicated below
a. proprioceptive sensory score on SIAS is more than 1
b knee-mouth test sore on SIAS is more than 2
c passive range of motion is minus 10 degrees for metacarpophalangeal joint extension
d finger test score on SIAS is 1A
3 ability to walk independently in daily life with or without assistance
4 ability to understand and consent the study protocol by himself

Key exclusion criteria

1.serious medical conditions for rehabilitation indicated below
a. severe heart disease
b. uncontrolled hypertension
c. history of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment
d. severe hepatic or renal dysfunction
e. severe orthopedic impairment
f. severe cognitive or psychiatric disorder
g. other serious medical conditions
2. pacemaker or other implanted stimulator use
3. history of seizures within 90 days before enrollment
4. participation of other clinical trial for regulatory approval within 90 days before enrollment
5.receiving other special neurorehabilitation technique for upper extremity paresis, such as trans cranial magnetic stimulation, therapeutic electrical stimulation, constraint induced movement therapy, and repetitive facilitative exercise, within 90 days before enrollment
6. injection of botulinum toxin or phenol for treatment of upper limb spasticity within 90 days before enrollment
7. impossible to record electroencephalography because of skin status or skull deformity
8. other critical problems to participate the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Katsuhiro
Middle name
Last name Mizuno

Organization

Keio University Hospital

Division name

Department of rehabilitation medicine

Zip code

160-8582

Address

35, Shinanomachi, Shinjukuku, Tokyo

TEL

03-3353-1211

Email

mizuno-k@keio.jp


Public contact

Name of contact person

1st name Kimiko
Middle name
Last name Tsuchiya

Organization

Keio University Hospital

Division name

Department of rehabilitation medicine

Zip code

160-8582

Address

35, Shinanomachi, Shinjukuku, Tokyo

TEL

03-5363-3833

Homepage URL


Email

ktsuchiya@keio.jp


Sponsor or person

Institute

Department of rehabilitation medicine,Keio University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan 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

Keio University Hospital Institutional Review Board

Address

35, Shinanomachi, Shinjukuku, Tokyo

Tel

03-3353-1211

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

慶應義塾大学病院(東京都)
済生会神奈川県病院(神奈川県)
東京湾岸リハビリテーション病院(千葉)
東京都リハビリテーション病院(東京)


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 02 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

2016 Year 12 Month 27 Day

Date of IRB

2016 Year 12 Month 27 Day

Anticipated trial start date

2017 Year 03 Month 03 Day

Last follow-up date

2018 Year 10 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

2017 Year 03 Month 02 Day

Last modified on

2024 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030299


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name