Functional electrical stimulation (FES) can restore limb movements through electrically initiated, coordinated contractions of paralyzed muscles. The peripheral nerve is an attractive site for stimulation using cuff electrodes. Many applications will require the electrode to selectively activate many smaller populations of axons within a common nerve trunk. The purpose of this study is to computationally model the performance of a flat interface nerve electrode (FINE) on the proximal femoral nerve for standing and stepping applications. Simulations investigated multiple FINE configurations to determine the optimal number and locations of contacts for the maximum muscular selectivity. Realistic finite element method (FEM) models were developed from digitized cross sections from cadaver femoral nerve specimens. Electrical potentials were calculated and interpolated voltages were applied to a double-cable axon model. Model output was analyzed to determine selectivity and estimate joint moments with a musculoskeletal model. Simulations indicated that a 22-contact FINE will produce the greatest selectivity. Simulations predicted that an eight-contact FINE can be expected to selectively stimulate each of the six muscles innervated by the proximal femoral nerve, producing a sufficient knee extension moment for the sit-to-stand transition and contributing 60% of the hip flexion moment needed during gait. We conclude that, whereas more contacts produce greater selectivity, eight channels are sufficient for standing and stepping with an FES system using a FINE on the common femoral nerve.

Objective. Sensory input in lower-limb amputees is critically important to maintaining balance, preventing falls, negotiating uneven terrain, responding to unexpected perturbations, and developing the confidence required for societal participation and public interactions in unfamiliar environments. Despite noteworthy advances in robotic prostheses for lower-limb amputees, such as microprocessor knees and powered ankles, natural somatosensory feedback from the lost limb has not yet been incorporated in current prosthetic technologies. Approach. In this work, we report eliciting somatic sensation with neural stimulation delivered by chronically-implanted, non-penetrating nerve cuff electrodes in two transtibial amputees. High-density, flexible, 16-contact nerve cuff electrodes were surgically implanted for the selective activation of sensory fascicles in the nerves of the posterior thigh above the knee. Electrical pulses at safe levels were delivered to the nerves by an external stimulator via percutaneous leads attached to the cuff electrodes. Main results. The neural stimulation was perceived by participants as sensation originating from the missing limb. We quantitatively and qualitatively ascertained the intensity, modality as well as the location and stability of the perceived sensations. Stimulation through individual contacts within the nerve cuffs evoked repeatable sensations of various modalities and at discrete locations projected to the missing toes, foot and ankle, as well as in the residual limb. In addition, we observed a high overlap in reported locations between distal versus proximal cuffs suggesting that the same sensory responses could be elicited from more proximal points on the nerve. Significance. Based on these findings, the high-density cuff technology is suitable for restoring natural sensation to lower-limb amputees and could be utilized in developing a neuroprosthesis with natural sensory feedback. The overlap in reported locations between proximal and distal cuffs indicates that our approach might be applicable to transfemoral amputees where distal muscles and branches of sciatic nerve are not available.

Electrical stimulation of the peripheral nerves has been shown to be effective in restoring sensory and motor functions in the lower and upper extremities. This neural stimulation can be applied via non-penetrating spiral nerve cuff electrodes, though minimal information has been published regarding their long-term performance for multiple years after implantation. Since 2005, 14 human volunteers with cervical or thoracic spinal cord injuries, or upper limb amputation, were chronically implanted with a total of 50 spiral nerve cuff electrodes on 10 different nerves (mean time post-implant 6.7 ± 3.1 years). The primary outcome measures utilized in this study were muscle recruitment curves, charge thresholds, and percent overlap of recruited motor unit populations. In the eight recipients still actively involved in research studies, 44/45 of the spiral contacts were still functional. In four participants regularly studied over the course of 1 month to 10.4 years, the charge thresholds of the majority of individual contacts remained stable over time. The four participants with spiral cuffs on their femoral nerves were all able to generate sufficient moment to keep the knees locked during standing after 2–4.5 years. The dorsiflexion moment produced by all four fibular nerve cuffs in the active participants exceeded the value required to prevent foot drop, but no tibial nerve cuffs were able to meet the plantarflexion moment that occurs during push-off at a normal walking speed. The selectivity of two multi-contact spiral cuffs was examined and both were still highly selective for different motor unit populations for up to 6.3 years after implantation. The spiral nerve cuffs examined remain functional in motor and sensory neuroprostheses for 2–11 years after implantation. They exhibit stable charge thresholds, clinically relevant recruitment properties, and functional muscle selectivity. Non-penetrating spiral nerve cuff electrodes appear to be a suitable option for long-term clinical use on human peripheral nerves in implanted neuroprostheses.

To maintain postural stability, unilateral lower-limb amputees (LLAs) heavily rely on visual and vestibular inputs, and somatosensory cues from their intact leg to compensate for missing somatosensory information from the amputated limb. When any of these resources are compromised, LLAs exhibit poor balance control compared to able-bodied individuals. We hypothesized that restoring somatosensation related to the missing limb via direct activation of the sensory nerves in the residuum would improve the standing stability of LLAs. We developed a closed-loop sensory neuroprosthesis utilizing non-penetrating multi-contact cuff electrodes implanted around the residual nerves to elicit perceptions of the location and intensity of plantar pressures under the prosthetic feet of two transtibial amputees. Effects of the sensory neuroprosthesis on balance were quantified with the Sensory Organization Test and other posturographic measures of sway. In both participants, the sensory neuroprosthesis improved equilibrium and sway when somatosensation from the intact leg and visual inputs were perturbed simultaneously. One participant also showed improvement with the sensory neuroprosthesis whenever somatosensation in the intact leg was compromised via perturbations of the platform. These observations suggest the sensory feedback elicited by neural stimulation can significantly improve the standing stability of LLAs, particularly when other sensory inputs are depleted or otherwise compromised.