This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety.
Aged 18 to 65 years old (inclusive), with no restriction on gender.
Having received implantation of any metallic objects or devices in the body (e.g., pacemaker, defibrillator, neurostimulator, cochlear implant, electronic devices, drug infusion pumps, etc.), excluding dental metallic implants or other implants confirmed to have no impact on the study.
Long-term use of anticoagulants or antiplatelet drugs prior to screening, with antiplatelet drugs not discontinued for at least 2 weeks before surgery; or suffering from hematological diseases such as aplastic anemia and systemic lupus erythematosus; or having clinically significant abnormal coagulation function during the screening period.
Having contraindications to magnetic resonance imaging (MRI) or being unable to complete MRI examinations for other reasons.
Being assessed by anesthesiologists as intolerant to anesthetic surgery.
Single group
WRS
DeviceWRS is a minimally invasive, wireless brain-machine interface system
success rate of brain-controlled tasks
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control task
success rate of brain-controlled tasks
The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control
Brain Control Fluency Index
Task Accuracy
Device Reliability
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Shanghai StairMed Technology Co., Ltd.
Lead sponsor
Huashan Hospital
Collaborator
