Overview
Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.
Eligibility
Inclusion Criteria:
- Age ≥18 years and ≤65 years, male or female;
- Tetraplegia due to C2-C5 cervical spinal cord injury, diagnosed per 2019 revised ISNCSCI of ASIA, injury grade A to B;
- Intact cognitive function, MoCA-BLIND score ≥19;
- Elbow flexor muscle strength ≤ Grade 3 by ISNCSCI;
- Neurological assessment confirms normal motor cortex function without significant organic or functional brain lesions;
- Tetraplegia diagnosed for ≥12 months, stable clinical status ≥6 months after standard treatment;
- Good compliance, voluntary participation; informed consent signed by subject or legal representative.
Exclusion Criteria:
- Syringomyelia, severe neuralgia or spasticity limiting training participation;
- Require tracheotomy, mechanical ventilation, nasogastric feeding to sustain vital functions;
- High surgical risk: active systemic infection, coagulation disorders, antithrombotic therapy users;
- Subjects implanted with CNS electrical stimulation medical devices;
- Unstable medical conditions, severe mental/cognitive disorders confounding endpoint assessment;
- Severe, unstable, uncontrolled complex regional pain syndrome;
- Autoimmune-induced spinal cord dysfunction/injury;
- History of stroke, multiple sclerosis, drug-resistant epilepsy, Alzheimer's Disease;
- Peripheral neuropathy;
- Pregnant/breastfeeding females, females planning pregnancy during trial;
- Require MRI examinations during device implantation period;
- Participated in other clinical trials within 1 month prior to enrollment;
- Investigator judges participation unsafe, or subject unlikely to complete protocol follow-up.
