Evaluating Safety and Effectiveness of Brain-Computer Interface Assisted Spinal Cord Stimulation and Exoskeleton System for Improving Walking in People with Chronic Spinal Cord Injury Aged 14 to 65

What this Trial Is About

Researchers are evaluating the safety and technical feasibility of a new brain-machine interface BCI-assisted spinal cord stimulation SCS combined with an exoskeleton EXS system in adults aged 14 to 65 with chronic spinal cord injury SCI. This study aims to determine if this system can safely and effectively improve lower limb motor function and quality of life in people who have had SCI for at least six months and have certain levels of motor impairment. Participants will receive implanted devices including high-density ECoG electrodes over the motor cortex and spinal cord stimulation electrodes at T11-L2. The system will be calibrated to synchronize the brain signals decoded by the BCI with the spinal cord stimulation and exoskeleton-assisted gait training. After implantation and calibration phases, participants will engage in daily one-hour training sessions, five times per week for one year, with ongoing adjustments to the system based on performance. Safety and efficacy will be assessed at multiple time points up to 12 months post-implantation. During the study, participants will be monitored through various assessments including motor function tests, neurophysiological measures, quality of life surveys, and device performance checks. Researchers will track adverse events and technical device data to evaluate safety. Follow-up visits will occur at 1, 2, 3, 6, and 12 months after device implantation. The study includes remote monitoring for device function and emergency support if needed, with a total participation time of at least one year.

BCI-Assisted SCS-EXS for Gait Optimization