BCI-Assisted SCS-EXS for Gait Optimization

The goal of this clinical trial is to evaluate the safety and technical feasibility of a novel brain-machine interface (BCI)-assisted spinal cord stimulation (SCS) and exoskeleton (EXS) system in patients with spinal cord injury (SCI). The primary aim is to determine whether the BCI-SCS-EXS system can safely and effectively improve lower limb motor function and quality of life in individuals with chronic SCI. Participant Population: Adults aged 14-65 years (sex/gender not limited). Patients with chronic SCI (≥6 months post-injury) classified as ASIA A, B, or C. Individuals with stable health status, MMSE ≥22, and secondary education or above. Primary Questions: 1. Is the BCI-SCS-EXS system safe and technically feasible for SCI rehabilitation? 2. Does the system improve lower limb motor function and quality of life in SCI patients? Interventions: Participants will undergo the following procedures: Phase I (Implantation): BCI implantation: ECoG electrodes placed over the motor cortex to decode lower limb movement intent. SCS electrode implantation: 5-6-5 paddle electrodes at T11-L2 for targeted spinal cord stimulation. Phase II (System Calibration): BCI-SCS synchronization: Calibration of decoded motor intent to trigger SCS parameters. SCS-EXO synchronization: Integration of SCS pulses with exoskeleton-assisted gait training. Phase III (Rehabilitation): Daily BCI-SCS-EXS training sessions (60 minutes, 5 times/week for 1 year). Adaptive adjustments to stimulation parameters and exoskeleton support based on performance. Remote monitoring of device performance and emergency intervention for technical issues. Outcome Measures: Primary: Safety (adverse events, device performance, synchronization metrics). Secondary: Efficacy (motor function, neurophysiological function, quality of life). Ethics and Safety: Informed consent will be obtained from all participants. Adverse events will be monitored and reported according to CTCAE 5.0 guidelines. Participan