Long-Term Outcomes of Epidural Spinal Cord Stimulation for People with Stable Spinal Cord Injuries

What this Trial Is About

Researchers are evaluating the long-term effects of chronic epidural spinal cord stimulation to help restore voluntary movement in adults with stable spinal cord injuries. This study focuses on patients with neurological damage below the C5 level and aims to assess changes in muscle activity power over a 10-year period. The study is sponsored by the University of Minnesota and involves ongoing monitoring and adjustment of spinal cord stimulator settings. Participants will receive epidural spinal cord stimulation using an implanted device that is already FDA approved and functional. They will visit the study site twice a year for a Brain Motor Control Assessment, during which different stimulator settings will be tested to observe their effects on muscle activation. The study includes no masking or placebo groups and focuses on measuring voluntary electromyography EMG power changes during these assessments. Over the 10 years of participation, individuals will undergo regular evaluations including the Brain Motor Control Assessment, spinal imaging of the stimulator system, and monitoring of device function and health status. Researchers will track changes in voluntary EMG power as the primary outcome and also study participants preferences for stimulation power. Participants must be medically stable and able to complete informed consent, with ongoing safety and rehabilitation monitoring to support their involvement throughout the study duration.

Epidural Stimulation After Neurologic Damage: Long-Term Outcomes