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

JRCT ID: jRCTs072240061

Registered date:25/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Upper-limb paralysis after cerebral infarction
• Date of first enrollment: 25/09/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Brain-machine interface

Outcome(s)

• Primary Outcome: Sum of change from baseline in Fugl-Meyer Assesment (FMA) hand and finger motor function item (B+C)

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both
• Include criteria: Less than 2-week post-stroke onset at the start of intervention

Exclude 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

Related Information

• Primary Sponsor: Shimodozono Megumi
• Source(s) of Monetary Support: LIFESCAPES Inc.