The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
Adults aged 18-65 years;
Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
Normal motor cortex function confirmed by neurological assessment;
Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
Patients with neuropsychiatric disorders or psychological impairments;
Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
Single group
Implant
DeviceImplantation of the device and follow-up
Adverse events
The incidence of adverse events associated with the device or surgical procedure
WRS Efficacy Assessment- Accuracy
Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better.
WRS Efficacy Assessment- Path efficiency
Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance.
WRS Efficacy Assessment- Time consumption
Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance.
Neurological Recovery Assessment
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status.
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