UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059236 |
|---|---|
| Receipt number | R000067754 |
| Scientific Title | Assessing Functional Brain Reorganization after Brain-Machine Interface Rehabilitation for Hand Paresis in Subacute Stroke. |
| Date of disclosure of the study information | 2025/09/30 |
| Last modified on | 2025/09/30 11:00:05 |
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Basic information
Public title
Assessing Functional Brain Reorganization after Brain-Machine Interface Rehabilitation for Hand Paresis in Subacute Stroke.
Acronym
Neural Changes after BMI Hand Therapy for Stroke
Scientific Title
Assessing Functional Brain Reorganization after Brain-Machine Interface Rehabilitation for Hand Paresis in Subacute Stroke.
Scientific Title:Acronym
Neural Changes after BMI Hand Therapy for Stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether a 2-week Brain-Machine Interface (BMI) training intervention induces changes in functional brain connectivity. To achieve this, we will acquire resting-state functional connectivity MRI (rs-fcMRI) scans before and after the training period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome Measure: Resting-state functional connectivity MRI (rsfcMRI)
Timepoint: Before and after the 2-week intervention
Key secondary outcomes
Fugl-Meyer Assessment
Stroke Impairment Assessment Set
Modified Ashworth Scale
Motor Activity Log
Functional Independence Measure
Range of Motion
Electroencephalogram (EEG)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A 2-week, non-invasive Brain-Machine Interface (BMI) intervention.
Interventions/Control_2
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
Age: Patients must be 18 years of age or older.
Diagnosis: Patients who present with upper limb paresis caused by a stroke.
Severity of Paresis: A total score of 47 or less on the upper extremity motor section of the Fugl-Meyer Assessment (FMA) for the affected limb.
Key exclusion criteria
Joint Contracture: Patients with a passive extension range of motion of the metacarpophalangeal joints in the paretic hand of less than -10 degrees (i.e., a flexion contracture exceeding 10 degrees).
Time Since Onset: Patients in the chronic phase, defined as 180 days or more since the onset of upper limb paresis.
Cognitive Function: Patients who are unable to provide informed consent or have impaired decision-making capacity.
Severe Comorbidities: Patients with severe, unstable medical conditions (e.g., malignancy) that may interfere with the study procedures or safety.
Pregnancy and Lactation: Women who are pregnant, breastfeeding, or have the possibility of being pregnant.
Implanted Electronic Devices: Patients with a cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic devices.
Implanted Magnetic/Metallic Materials: Patients with ferromagnetic materials in the body, such as intracranial aneurysm clips, surgical clips, cochlear implants, or artificial eyes.
Tattoos and Permanent Makeup: Patients with extensive tattoos (particularly those containing metallic dyes) or permanent makeup (e.g., eyeliner, eyebrows) that may cause burns during MRI.
Claustrophobia: Patients with a history of severe claustrophobia.
Inability to Maintain Position: Patients who are unable to remain in a supine position for approximately 30 minutes.
EEG Acquisition: Patients with scalp conditions or cranial deformities that would prevent the acquisition of a quality electroencephalogram (EEG).
Participation in Other Trials: Patients who have previously participated in other investigational trials for upper limb paresis.
Prior Antispasmodic Treatments: Patients who have previously received botulinum toxin therapy or nerve blocks (e.g., phenol block) for spasticity in the affected upper limb.
Investigator's Discretion: Patients deemed unsuitable for participation in the study for any reason by the investigator or physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohide |
| Middle name | |
| Last name | Shirasaka |
Organization
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Division name
Rehabilitation Division, Department of Medical
Zip code
080-0833
Address
2-1 Inadacho Kisen, Obihiro City, Hokkaido
TEL
0155-47-5700
hokutopt.takahashi@gmail.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Division name
Physical Therapy Division, Department of Rehabilitation
Zip code
080-0833
Address
2-1 Inadacho Kisen, Obihiro City, Hokkaido
TEL
0155-47-5700
Homepage URL
hokutopt.takahashi@gmail.com
Sponsor or person
Institute
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
medical ethics committee
Address
7-5, Inada-cho Kisen, Obihiro City, Hokkaido, Japan
Tel
0155-48-8000
crc@hokuto7.or.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 | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 28 | 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 | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067754
