Efficacy and Safety of Brain-Machine Interface Treatment for Acute Stroke Patients with Upper Limb Paralysis

Efficacy and Safety of Brain-Machine Interface Treatment for Acute Stroke Patients with Upper Limb Paralysis - Efficacy and Safety of Brain-Machine Interface

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs072240061

Enrollment

Registered

2024-09-25

Start date

2024-12-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper-limb paralysis after cerebral infarction or cerebral hemorrhage

Interventions

Brain-machine interface

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Less than 2-week post-stroke onset at the start of intervention

Exclusion criteria

Exclusion criteria: (1) Patients who have difficulty using BMI. Specific examples are as follows. (1)-1 Serious cardiac disease (1)-2 Poorly controlled hypertension (1)-3 Pulmonary embolism, acute pulmonary heart, or severe pulmonary hypertension within 90 days prior to study entry (1)-4 Complication of serious hepatic or renal dysfunction (1)-5 Complication of serious orthopedic disease that interferes with exercise (1)-6 Complications of severe cognitive impairment and severe psychiatric disorders (1)-7 Patients unable to wear a headset or motorized orthosis (1)-8 Patients with pacemakers or implantable cardioverter-defibrillators (1)-9 People with significant pain at the site of application (1)-10 People with febrile illness (1)-11 People with skin sensory disturbance (1)-12 People with difficulty in applying electrodes due to active skin disease (in case of infection), etc. (1)-13 People with malignant tumor or tuberculous disease (1)-14 People with severe spasticity or contracture (1)-15 Pregnant women (2)Patients who are judged by the physician to be inappropriate to participate in this study

Design outcomes

Primary

Measure	Time frame
Sum of change from baseline in Fugl-Meyer Assesment (FMA) hand and finger motor function item (B+C)	—

Secondary

Measure	Time frame
(1) FMA upper limb evaluation (sum score from A-D/each score from A to D) (2) Motor Activity Log (MAL) (3) Electromyogram (EMG) of finger extensor and flexor muscles during hand extension/flexion (4) Electroencephalogram (EEG) during BMI treatment (5) Modified Ashworth Scale (MAS) (6) Functional Independence Measure (FIM) (7) National Institutes of Health Stroke Scale (NIHSS) (8) mRS (modified Rankin Scale) (9) EEG using high-density electroencephalograph and other electrophysiological tests (10) Magnetic Resonance Imaging (MRI) (11) Motor Evoked Potential (MEP) (12) Kinematic evaluation (video, etc.) (13) Action Research Arm Test (ARAT), Box and Block Test (BBT) and other upper extremity assessment tests	—

Measure

Time frame

(1) FMA upper limb evaluation (sum score from A-D/each score from A to D) (2) Motor Activity Log (MAL) (3) Electromyogram (EMG) of finger extensor and flexor muscles during hand extension/flexion (4) Electroencephalogram (EEG) during BMI treatment (5) Modified Ashworth Scale (MAS) (6) Functional Independence Measure (FIM) (7) National Institutes of Health Stroke Scale (NIHSS) (8) mRS (modified Rankin Scale) (9) EEG using high-density electroencephalograph and other electrophysiological tests (10) Magnetic Resonance Imaging (MRI) (11) Motor Evoked Potential (MEP) (12) Kinematic evaluation (video, etc.) (13) Action Research Arm Test (ARAT), Box and Block Test (BBT) and other upper extremity assessment tests

—

Contacts

Public ContactKentaro Kawamura

Kagoshima University Hospital

kentarok@m.kufm.kagoshima-u.ac.jp+81-99-275-5339

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026