臨床研究等提出・公開システム

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

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

Shimodozono Megumi

Kagoshima University Hospital

8-35-1, Sakuragaoka, Kagoshima-City, Kagoshima

rihakoza@m2.kufm.kagoshima-u.ac.jp

Kawamura Kentaro

Kagoshima University Hospital

8-35-1, Sakuragaoka, Kagoshima-City, Kagoshima

+81-99-275-5339

kentarok@m.kufm.kagoshima-u.ac.jp

Recruiting

Sept. 25, 2024

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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

(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

Both

Upper-limb paralysis after cerebral infarction or cerebral hemorrhage

Brain-machine interface

056

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

(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

+81-99-275-6624

July. 01, 2024

Yes

IPD obtained in this study (EDC input data, datasets for statistical analysis) may be used in other studies or provided to studies carried out at other institutions.

none