UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057216 |
|---|---|
| Receipt number | R000064684 |
| Scientific Title | Efficacy and Cost-effectiveness of Brain-Machine Interface Therapy in Stroke Patients with Upper-extremity Paralysis: A Single-blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2026/03/11 11:04:18 |
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Basic information
Public title
Efficacy and Cost-effectiveness of Brain-Machine Interface Therapy in Stroke Patients with Upper-extremity Paralysis
Acronym
ECOBITS Trial
Scientific Title
Efficacy and Cost-effectiveness of Brain-Machine Interface Therapy in Stroke Patients with Upper-extremity Paralysis: A Single-blind Randomized Controlled Trial
Scientific Title:Acronym
ECOBITS Trial
Region
| Japan |
Condition
Condition
Stroke (Cerebral Infarction,Intracerebral Hemorrhage,Subarachnoid Hemorrhage)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to evaluate the effect of brain-machine interface (BMI) technology on improving upper limb function in hospitalized patients with severe upper limb paralysis within 60 days of stroke onset compared to a control group receiving conventional rehabilitation only.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) motor score at day 30 after randomization
Key secondary outcomes
FMA-UE subscales, sensory assessment (10-point scale), Modified Ashworth Scale, Functional Independence Measure, finger muscle EMG, EQ-5D-5L
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Brain-Machine Interface (BMI) therapy for 20 minutes/session, 5 sessions/week for 4 weeks (total 20 sessions) plus conventional rehabilitation
Interventions/Control_2
Conventional rehabilitation including electrical stimulation, upper limb stretching, range of motion exercises, and upper limb movement training
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. Stroke patients (hemorrhage, infarction, or subarachnoid hemorrhage) within 60 days of onset
2. Severe upper limb paresis:
Passive extension range of motion >= -10 degrees at fingers' MP joints
Initial FMA-UE (upper extremity motor function score) <= 30
3. Age >= 18 years
4. Capable of providing informed consent (for patients with motor aphasia, consent can be obtained by proxy after confirming patient's understanding using SLTA)
Key exclusion criteria
1. Patients unable to undergo rehabilitation (neurological diseases, severe comorbidities, cognitive dysfunction [MMSE<21, except for motor aphasia], psychiatric disorders)
2. Patients with cardiac pacemaker or implantable cardioverter-defibrillator
3. Patients who participated in another clinical trial or clinical research within the year prior to participating in the research
4. Prior botulinum toxin therapy or nerve block before enrollment
5. Patients unable to undergo EEG measurement
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Sakata |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Research Department
Zip code
151-0053
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
+81-3-6712-6401
sakata.nobuo@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kanasaki |
Organization
Heisei Medical Welfare Group Research Institute
Division name
Administrative division
Zip code
151-0053
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
+81-3-6712-6401
Homepage URL
kanasaki.noriko@hmw.gr.jp
Sponsor or person
Institute
Heisei Medical Welfare Group Research Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
LIFESCAPES Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Heisei Medical Welfare Group Research Institute Ethics Review Committee
Address
1-3-1 Yoyogi, Shibuya-ku, Tokyo, Japan
Tel
+81-3-6172-6401
info.research@hmw.gr.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
| 2025 | Year | 03 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064684
