The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients.
WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.
Aged 18-80 years (inclusive), any gender.
Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
Unable to tolerate anesthesia or surgery.
Severe neurological disorders or brain injury leading to significant dysfunction.
Shanghai StairMed Technology Co., Ltd.
Lead sponsor
Huashan Hospital
Collaborator