Pilot Study of Combined Injury-site and Lumbosacral Epidural Spinal Cord Stimulation for Improving Motor Function in Adults with Spinal Cord Injury

What this Trial Is About

Researchers are investigating spinal cord stimulation SCS as a method to improve motor and autonomic function in adults with chronic complete spinal cord injury SCI. This study aims to determine whether applying SCS to both the injury site and the lumbrosacral spinal cord can enhance motor recovery compared to stimulation of the lumbrosacral area alone. Previous studies have shown that SCS can activate previously paralyzed muscles and help restore function in chronic paralysis. Participants will undergo standard surgery to implant spinal cord stimulators with leads placed at the injury site and the lumbrosacral spinal cord. The study includes three phases of intervention lasting three months each first, activation of SCS over the lumbrosacral spinal cord second, activation over the injury site only and third, activation over both areas simultaneously. Throughout all phases, participants will receive physiotherapy targeting lower limb muscles and engage in exoskeleton training for 4 to 5 hours weekly. During the trial, participants will be assessed for improvements in standing, stepping, walking ability, gait, and lower limb sensation from baseline to three months after the third phase. Researchers will also monitor changes in pain intensity, quality of life, psychological symptoms, and neuropathic pain. The total intervention and follow-up period includes nine months of stimulation phases plus three months of post-treatment observation, with evaluations conducted at regular intervals to track progress.

Combined Injury-site & Lumbosacral Epidural Spinal Cord Stimulation