Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand?

This paper describes the preliminary performance of a surgically implanted neuroprosthesis for standing and transfers after spinal cord injury (SCI) in an initial group of 12 volunteers with longstanding paralysis. The CWRU/VA standing neuroprosthesis consists of an 8-channel implanted receiver-stimulator, epimysial and surgically implanted intramuscular electrodes, and a programmable wearable external controller. After reconditioning exercise and rehabilitation with the system, most individuals with paraplegia or low tetraplegia were able to stand, transfer, and release one hand from a support device to manipulate objects in the environment or to perform swing-to ambulation in a walker. The effort and assistance required for transfers were reduced for users with mid-level tetraplegia, although the maneuvers were not independent. Neuroprosthesis users with tetraplegia and paraplegia alike benefited from the improvements in their general health derived from exercise, including reduced risk of decubiti and self-reported modulation of spasticity. Stimulated responses are stable and sufficiently strong for function, and implanted components are reliable with a 90% probability of epimysial electrode survival at 4 years post-implant. The techniques employed are repeatable and teachable, and suitable for multi-center clinical trial.

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.

Implanted Functional Neuromuscular Stimulation systems for individuals with cervical spinal cord injuries: clinical case reports.

OBJECTIVE: To determine the feasibility of providing the ability to stand and to facilitate the performance of standing transfers to individuals with cervical-level spinal cord injuries via functional neuromuscular stimulation (FNS). The applicability of implantable technology to this population was investigated, and the characteristics of the potential system users were explored. The effects of FNS on the effort and assistance required to stand and complete standing transfers were examined. SETTING: Institutional rehabilitation practice. DESIGN: Nonrandomized controlled trial. PATIENTS: Twenty-four individuals with low cervical spinal cord injuries were evaluated for inclusion in a program of lower extremity FNS, four of whom received the intervention. INTERVENTION: Chronically indwelling percutaneous intramuscular electrodes were used to exercise the hip, knee, and trunk extensors and develop activation patterns to produce standing function. These temporary systems were then replaced with silicone-enclosed helical wire electrodes suitable for eventual use with an eight-channel implantable receiver/stimulator. MAIN OUTCOME MEASURES: Full sensory and motor evaluations were performed and physical contraindications to stimulation were catalogued. For active subjects, American Spinal Injury Association Total Motor Scores with and without FNS were recorded, along with quadriceps strength and ability to complete exercise, standing, controlled sitting, and standing transfer maneuvers. Performances of implanted electrodes were determined by the stability of recruitment properties, impedances or surface potentials, and serial radiographs. RESULTS: Motor scores increased an average of nine points with stimulation over baseline volitional values. With FNS, all four volunteers were able to exercise, stand, and sit independently or with minimal assistance. Although they required varying degrees of assistance with the pivot phase of the transfer maneuver, all were able to raise and lower their body weight independently with stimulation and to use the system to facilitate standing transfers. One participant received the implantable receiver/stimulator, which remains operational at follow-up more than 3 years later. CONCLUSION: FNS can provide the ability to exercise, stand, and transfer to individuals with tetraplegia, even in the presence of medical complications and upper extremity impairment. FNS facilitates standing transfers by eliminating the heavy lifting usually required by a caregiver, thus decreasing the effort and assistance necessary to gain access to places impossible to approach with conventional sliding transfers.