Effectiveness and safety evaluation of electroencephalography-based brain machine interface rehabilitation system (PN-S3219010) for patients with severe hemiparetic stroke: a randomized clinical trial for regulatory approval. - The BEST-BRAIN trial

Department of rehabilitation medicine,Keio University Hospital0 个研究点目标入组 40 人开始时间: 2017年3月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.serious medical conditions for rehabilitation indicated below a. severe heart disease b. uncontrolled hypertension c. history of pulmonary embolism, acute pulmonary heart disease, or severe pulmonary hypertension within 90 days before enrollment d. severe hepatic or renal dysfunction e. severe orthopedic impairment f. severe cognitive or psychiatric disorder g. other serious medical conditions 2. pacemaker or other implanted stimulator use 3. history of seizures within 90 days before enrollment 4. participation of other clinical trial for regulatory approval within 90 days before enrollment 5.receiving other special neurorehabilitation technique for upper extremity paresis, such as trans cranial magnetic stimulation, therapeutic electrical stimulation, constraint induced movement therapy, and repetitive facilitative exercise, within 90 days before enrollment 6. injection of botulinum toxin or phenol for treatment of upper limb spasticity within 90 days before enrollment 7. impossible to record electroencephalography because of skin status or skull deformity 8. other critical problems to participate the study

发起方

Department of rehabilitation medicine,Keio University Hospital