A Clinical Study of a Fully Implanted, Wireless and Functional BCI for Upper-Limb Functional Replacement in Tetraplegia Due to Spinal Cord Injury: Efficacy and Safety

This trial adopts a prospective, multicenter, single-arm target value study design.

All enrolled subjects will receive implantation of an implantable brain-computer interface system for compensatory hand motor function, followed by standardized brain-computer training (including brain-controlled pneumatic gloves). Follow-up assessments will be conducted at 1, 2, 3 and 6 months after implantation to evaluate the safety and efficacy of the investigational medical device for upper-limb functional replacement in patients with tetraplegia caused by spinal cord injury.

Inclusion criteria

• 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;
• Neurological assessment confirms normal motor-related cortical function of the brain, with no acute cerebral functional changes;
• At least 12 months have elapsed since the cervical spinal cord injury resulting in tetraplegia, and the condition has been stable for at least 6 months following standardized treatment (with documentation of rehabilitation therapy records available);
• Good cognitive function: Mini-Mental State Examination (MMSE) score ≥ 22 and Montreal Cognitive Assessment (MoCA) score ≥ 26 ;
• Possess the basic visual, auditory, and language comprehension abilities required for interaction, and be able to cooperate with training;
• The subject voluntarily participates and is willing to comply with the relevant examinations and follow-up visits.

Exclusion criteria

• 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;
• Other ongoing medical interventions that may affect the benefit from BCI intervention (e.g., dependence on ventilator support, tracheostomy, nasogastric tube feeding, etc.);
• Presence of psychiatric or psychological disorders that may interfere with the subject's participation in BCI training, such as depression (HAMD ≥ 18 points) or anxiety disorder (HAMA ≥ 14 points) ;
• Presence of active infection; severe coagulation abnormalities (activated partial thromboplastin time (APTT) or prothrombin time (PT) > 2.5 × upper limit of normal); or other severe systemic diseases that, as assessed by the investigator, may significantly increase surgical risk or interfere with neurological function assessment or system use;
• Contraindications to surgery or anesthesia, or deemed unsuitable for implantation surgery by anesthesiology/surgical assessment;
• Fever, or vital signs and/or intracranial status not yet stabilized;
• Upper-limb motor dysfunction due to other etiologies, such as amyotrophic lateral sclerosis, syringomyelia, spinal vascular diseases, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, peripheral nerve injury, tendon rupture, etc.;
• Planned MRI examination during the device implantation period;
• Life expectancy < 6 months (e.g., severe end-stage diseases);
• Participation in other drug or medical device clinical trials within the past 1 month;
• Pregnant or breastfeeding women;
• Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.