Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury.

This study describes the performance of surgically-implanted epimysial stimulating electrodes in the muscles of the lower extremities for use in functional neuromuscular stimulation (FNS) systems for standing after spinal cord injury. A total of 86 epimysial electrodes were implanted in 13 volunteers with low tetraplegia or paraplegia receiving the Case Western Reserve University/Veteran Affairs (CWRU/VA)-implanted standing/transfer neuroprosthesis. The neuroprosthesis consisted of bilateral epimysial electrodes in the knee and hip extensors (vastus lateralis, gluteus maximus, and adductor magnus or semimembranosus) and intramuscular electrodes at the T12/L1 or L1/L2 spinal roots for trunk extension. Recruitment properties, stimulated knee and hip extension moments, standing performance, and mechanical integrity over time were measured for a period up to four years post-implantation. Stimulated thresholds were stable and recruitment was sufficient to generate joint moments adequate for standing, with up to 97% body weight supported by the legs. Four mechanical failures were observed, all in the posterior muscles of the thigh, leaving 95% of all electrodes operational at all followup intervals. Probability of 24-month survival is estimated to be 93% plateauing to a steady state of 90% at four years. These results indicate that epimysial designs are appropriate for long-term clinical use in the large muscles of the lower extremities with implanted motor system neuroprostheses.