This prospective, multicenter, single-arm clinical trial will enroll subjects with tetraplegia secondary to spinal cord injury. An implantable brain-computer interface system for compensatory hand motor function will be used to reconstruct upper-limb function, so as to evaluate the safety and clinical efficacy of this device in achieving upper-limb functional replacement.
18 years ≤ age ≤ 65 years, male or female;
Cervical spinal cord injury (injury level C2-C6), with ASIA Impairment Scale grade A, B, or C;
Severe impairment of hand function on the target upper extremity: finger flexor muscle strength < grade 3 as assessed by the ISNCSCI scale;
ARAT score ≥ 2 for "hand to mouth"; score ≥ 1 for both "hand to top of head" and "hand to back of head"; and scores ≤ 1 for each of the grasp, grip, and pinch tasks;
Neurodegenerative diseases / secondary injury due to tumors, or severe autonomic dysreflexia;
Presence of intracranial lesions or contraindications to intracranial implantation: active epilepsy or definite epileptogenic tendency; severe cerebrovascular disease; brain tumor; moderate-to-severe sequelae of traumatic brain injury; space-occupying lesions or structural abnormalities at the electrode implantation target area; already implanted with active implantable electronic devices such as cardiac pacemakers/defibrillators, cochlear implants, deep brain stimulators, or drug infusion pumps, or presence of local metal foreign bodies/implants in the area to be implanted; or other contraindications to intracranial implantation as assessed by the investigator;
Malignancies in other organ systems;
Cardiovascular system diseases: severe cardiac insufficiency, severe arrhythmias, or uncontrolled hypertension;
NeuroXess Technology (shanghai) Co.,Ltd.
Lead sponsor
Huashan Hospital
Collaborator