Evaluation of the effectiveness and safety of treatment using brain-machine interface to the patients with post-stroke upper limb paralysis

eki Yoshino0 个研究点目标入组 40 人开始时间: 2023年10月17日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•(1) Patients for whom 10 days or more have passed since the onset of stroke
•(2) Age 20 years or older
•(3) Adult patients with upper limb paralysis after their first stroke who meet the following criteria:
•(3)-1 Patients who have not lost deep sensation in the paralyzed finger
•(3)-2 Patients whose range of motion in passive extension of the MP joint of the paralyzed finger is -10 degrees or more
•(3)-3 Patients with severe to moderate motor function of the paralyzed hand (e.g. 40 points or less on the Fugl-Meyer Assessment)
•(4) Patients who can give their own written consent. If the subject has sufficient ability to consent, but has difficulty writing due to paralysis or aphasia, confirm the subject's consent and obtain written consent from a surrogate writer.

•(1) Patients for whom it is difficult to perform BMI. A specific example is below.
•(1)-1 Serious heart disease
•(1)-2 Uncontrolled hypertension
•(1)-3 Complications of pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension within 90 days before the start of the study
•(1)-4 Complications of severe liver/kidney dysfunction
•(1)-5 Complications of serious orthopedic disease that impede movement
•(1)-6 Severe cognitive impairment, comorbidity of severe mental illness
•(1)-7 Patients who cannot wear a headset or electric orthosis
•(1)-8Persons using a pacemaker or implantable defibrillator
•(1)-9 People who have significant pain at the attachment site
•(1)-10 People with febrile illness
•(1)-11 People with skin sensitivity disorder
•(1)-12 People who have difficulty attaching electrodes due to active skin disease (infectious diseases), etc.
•(1)-13 Persons with malignant tumor or tuberculosis disease
•(1)-14 People with severe spasticity or contracture
•(1)-15 Pregnant women

发起方

eki Yoshino