Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

A Prospective, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

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.

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.