Selectivity of intramuscular stimulating electrodes in the lower limbs.

Intramuscular (IM) electrodes have been used safely and effectively for decades to activate paralyzed muscles in neuroprosthetic systems employing functional electrical stimulation (FES). However, the response to stimulation delivered by these and any type of electrode can be limited by a phenomenon known as spillover, in which the stimulus intended to produce a contraction in a particular muscle inadvertently activates another muscle, causes adverse sensation, or triggers undesired reflexes. The purpose of this retrospective study was to determine the selectivity of monopolar intramuscular stimulating electrodes implanted in the lower limbs of individuals with motor and sensory complete paraplegia secondary to spinal cord injury (SCI) and to catalog the most common electrode spillover patterns. The performance records of 602 electrodes from 10 subjects who participated in a program of standing and walking with FES in our laboratory over the past decade were examined. Sixty percent (358) of these electrodes were "stable" (i.e., stimulated responses were consistent during the first 6 months postimplant), and 32% of all stable electrodes (113) exhibited spillover as noted in clinical and laboratory records. Common spillover patterns for eight muscle groups were tabulated and analyzed in terms of their functional implications. The beneficial (activation of synergistic muscles) or deleterious (activation of compromising reflexes, antagonists, or adverse sensation) effects of spillover were highly context dependent, with several potentially useful spillover patterns in certain phases of gait becoming undesirable and limiting in others. Knowledge of the selectivity of intramuscular electrodes and the patterns of spillover they exhibit should guide surgeons and rehabilitationists installing lower-limb neuroprostheses during the implantation process and allow them to better predict the ultimate functional usefulness of the electrodes they choose.

Surgical technique for installing an eight-channel neuroprosthesis for standing.

A standardized surgical procedure to implant an eight-channel functional neuromuscular stimulation system in the lower extremities for standing, exercise, and transfers for individuals with spinal cord injury has been developed. The implanted components include: (1) one eight-channel receiver-stimulator, (2) epimysial electrodes, (3) intramuscular electrodes, and (4) inline connectors. The development process included identifying the target muscle set for electrode placement and the corresponding surgical approaches, determining the stages of the surgical procedure, and assessing the effectiveness and stability of the implanted neuroprosthesis. The bilateral muscle set consists of the vastus lateralis, the gluteus maximus, the semimembranosus, and the erector spinae. Surgical approaches to the nerve entry points were developed through a series of cadaveric studies and intraoperative tests. Electrode placement is related to bony landmarks and based on standard orthopaedic approaches. The components of the neuroprosthesis are installed in one surgical session, with three stages. This procedure has been applied successfully in seven individuals, resulting in strong, isolated stimulated contractions adequate to raise and lower the body, maintain standing with a walker, and perform pivot transfers. The standardized surgical procedure is repeatable and teachable and will be used in upcoming multicenter clinical trials of the implanted neuroprosthesis.

Implanted functional electrical stimulation system for mobility in paraplegia: a follow-up case report.

A 16-channel functional electrical stimulation (FES) system has been implanted in a person with T10 paraplegia for over a year. The system consists of two eight-channel radio frequency controlled receiver-stimulators delivering stimuli through a network of 14 epimysial and two intramuscular electrodes. Using this system and a walker for support, the subject was able to stand up for 8 min and walk regularly for 20 m. The standing duration was limited by arm fatigue since upper extremities supported an average of 25% of body weight. This was due to suboptimal hip extension and some undesired recruitment of rectus femoris and sartorius with stimulation of quadriceps electrodes. The left quadriceps exhibited rapid fatigue that limited walking distance and duration. The metabolic energy requirements were well within the aerobic limits of the sedentary paraplegic population. At one-year follow-up evaluation all electrodes are functional except one intramuscular electrode. The implant caused no adverse physiological effects and the individual reported health benefits such as increased energy and overall fitness as a result of the FES system use. With further improvements in muscle response through innovative surgical techniques, the 16-channel implanted FES system can be a viable addition to exercise and mobility function in persons with paraplegia.

Implantation of a 16-channel functional electrical stimulation walking system.

A 16-channel electrical stimulation system was implanted in a 39-year-old patient with T10 paraplegia to restore sit to stand, walking, and exercise functions. System implantation required two surgical sessions. In the first session, the posterior muscle set consisting of bilateral semimembranosus, adductor magnus, and gluteus maximus muscles were exposed and epimysial electrodes sutured at the point of greatest muscle contraction. Closed double helix intramuscular electrodes were implanted in the erector spinae. Two weeks later, epimysial electrodes were attached to the eight anterior muscles consisting of the tibialis anterior, sartorius, tensor fasciae latae, and vastus lateralis with all 16 electrode leads passed to the anterior abdominal wall. The electrodes were connected to two eight-channel stimulators placed in the iliac fossae, and the system was checked by activating the individual muscles. The implanted stimulators received stimulation instructions and power via a radio frequency link to an external control. Stimulation patterns for standing, walking, sitting, and exercise functions were chosen from a preprogrammed menu via a finger key pad. After 3 weeks of restricted patient activity, all electrodes stimulated either the target muscle or had an acceptable spillover pattern. The patient is undergoing a 16-week rehabilitation course of stimulated exercises gradually increasing in intensity. At the conclusion, the goal is to discharge the patient with the system for spontaneous use. Although long term followup is required to determine system reliability, preliminary clinical results indicate that targeted, repeatable, functional muscle contractions in the lower extremity can be achieved with a system consisting of epimysial electrodes.