Walking after incomplete spinal cord injury with an implanted neuromuscular electrical stimulation system and a hinged knee replacement: a single-subject study.

STUDY DESIGN: Single-subject repeated measures study. OBJECTIVES: Neuromuscular electrical stimulation (NMES) can enhance walking for people with partial paralysis from incomplete spinal cord injury (iSCI). This single-subject study documents an individual's experience who both received an experimental implanted NMES system and underwent clinical bilateral hinged total knee arthroplasty (TKA). She walked in the community with knee pain prior to either intervention. Walking performance improved with an implanted NMES system. Knee pain and instability continued to worsen over time and eventually required TKA. This study evaluates the effects of these interventions. SETTING: Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland OH, USA. METHODS: The differential and combined effects of NMES and hinged knee replacement were assessed in terms of walking speed, toe clearance, knee angle, and participant perceptions with and without stimulation assistance both before and after TKA. RESULTS: The combined approach both reduced pain and restored walking ability to levels achieved prior to developing significant knee pain that prevented walking without NMES. There was an interaction effect between NMES and TKA on walking speed. Toe clearance consistently improved with stimulation assistance and TKA prevented significant knee hyperextension. The greatest impact was on endurance. Knee replacement re-enabled long distance walking with the addition of stimulation again more than doubling her maximum walking distance from 214 to 513 m. CONCLUSIONS: These data support further research of combined implantable interventions that may benefit people with iSCI. Furthermore, joint laxity and pain may not necessarily be contraindications to NMES if addressed with conventional clinical treatments.

Chronic nerve health following implantation of femoral nerve cuff electrodes.

BACKGROUND: Peripheral nerve stimulation with implanted nerve cuff electrodes can restore standing, stepping and other functions to individuals with spinal cord injury (SCI). We performed the first study to evaluate the clinical electrodiagnostic changes due to electrode implantation acutely, chronic presence on the nerve peri- and post-operatively, and long-term delivery of electrical stimulation. METHODS: A man with bilateral lower extremity paralysis secondary to cervical SCI sustained 5 years prior to enrollment received an implanted standing neuroprosthesis including composite flat interface nerve electrodes (C-FINEs) electrodes implanted around the proximal femoral nerves near the inguinal ligaments. Electromyography quantified neurophysiology preoperatively, intraoperatively, and through 1 year postoperatively. Stimulation charge thresholds, evoked knee extension moments, and weight distribution during standing quantified neuroprosthesis function over the same interval. RESULTS: Femoral compound motor unit action potentials increased 31% in amplitude and 34% in area while evoked knee extension moments increased significantly (p < 0.01) by 79% over 1 year of rehabilitation with standing and quadriceps exercises. Charge thresholds were low and stable, averaging 19.7 nC ± 6.2 (SEM). Changes in saphenous nerve action potentials and needle electromyography suggested minor nerve irritation perioperatively. CONCLUSIONS: This is the first human trial reporting acute and chronic neurophysiologic changes due to application of and stimulation through nerve cuff electrodes. Electrodiagnostics indicated preserved nerve health with strengthened responses following stimulated exercise. Temporary electrodiagnostic changes suggest minor nerve irritation only intra- and peri-operatively, not continuing chronically nor impacting function. These outcomes follow implantation of a neuroprosthesis enabling standing and demonstrate the ability to safely implant electrodes on the proximal femoral nerve close to the inguinal ligament. We demonstrate the electrodiagnostic findings that can be expected from implanting nerve cuff electrodes and their time-course for resolution, potentially applicable to prostheses modulating other peripheral nerves and functions. TRIAL REGISTRATION: ClinicalTrials.gov NCT01923662 , retrospectively registered August 15, 2013.

Oxygen Consumption While Walking With Multijoint Neuromuscular Electrical Stimulation After Stroke.

This case study evaluated the effect of implanted multijoint neuromuscular electrical stimulation gait assistance on oxygen consumption relative to walking without neuromuscular electrical stimulation after stroke. The participant walked slowly with an asymmetric gait pattern after stroke. He completed repeated 6-min walk tests at a self-selected walking speed with and without hip, knee, and ankle stimulation assistance. His walking speed with neuromuscular electrical stimulation more than doubled from 0.28 ± 0.01 m/sec to 0.58 ± 0.04 m/sec, whereas average step length and cadence increased by 0.12 m and 24 steps/min, respectively. As a result, energy cost of walking with neuromuscular electrical stimulation decreased by 0.19 ml O2/kg per meter as compared with walking without stimulation while oxygen consumption increased by 1.1 metabolic equivalent of tasks (3.9 ml O2/kg per minute). These metabolic demands are similar to those reported for stroke survivors capable of walking at equivalent speeds without stimulation, suggesting the increase in oxygen consumption and decreased energy cost result from improved efficiency of faster walking facilitated by neuromuscular electrical stimulation. Although the effect of neuromuscular electrical stimulation on gait economy has implications for community walking within the user's metabolic reserves, this case study's results should be interpreted with caution and the hypothesis that multijoint neuromuscular electrical stimulation improves metabolic efficiency should be tested in a wide population of stroke survivors with varied deficits.

Impact of an implanted neuroprosthesis on community ambulation in incomplete SCI.

OBJECTIVE: Test the effect of a multi-joint control with implanted electrical stimulation on walking after spinal cord injury (SCI). DESIGN: Single subject research design with repeated measures. SETTING: Hospital-based biomechanics laboratory and user assessment of community use. PARTICIPANTS: Female with C6 AIS C SCI 30 years post injury. INTERVENTIONS: Lower extremity muscle activation with an implanted pulse generator and gait training. OUTCOME MEASURES: Walking speed, maximum distance, oxygen consumption, upper extremity (UE) forces, kinematics and self-assessment of technology. RESULTS: Short distance walking speed at one-year follow up with or without stimulation was not significantly different from baseline. However, average walking speed was significantly faster (0.22 m/s) with stimulation over longer distances than volitional walking (0.12 m/s). In addition, there was a 413% increase in walking distance from 95 m volitionally to 488 m with stimulation while oxygen consumption and maximum upper extremity forces decreased by 22 and 16%, respectively. Stimulation also produced significant (P ≤ 0.001) improvements in peak hip and knee flexion, ankle angle at foot off and at mid-swing. CONCLUSION: An implanted neuroprosthesis enabled a subject with incomplete SCI to walk longer distances with improved hip and knee flexion and ankle dorsiflexion resulting in decreased oxygen consumption and UE support. Further research is required to determine the robustness, generalizability and functional implications of implanted neuroprostheses for community ambulation after incomplete SCI.

"Long-term stability of stimulating spiral nerve cuff electrodes on human peripheral nerves".

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A muscle-driven approach to restore stepping with an exoskeleton for individuals with paraplegia.

BACKGROUND: Functional neuromuscular stimulation, lower limb orthosis, powered lower limb exoskeleton, and hybrid neuroprosthesis (HNP) technologies can restore stepping in individuals with paraplegia due to spinal cord injury (SCI). However, a self-contained muscle-driven controllable exoskeleton approach based on an implanted neural stimulator to restore walking has not been previously demonstrated, which could potentially result in system use outside the laboratory and viable for long term use or clinical testing. In this work, we designed and evaluated an untethered muscle-driven controllable exoskeleton to restore stepping in three individuals with paralysis from SCI. METHODS: The self-contained HNP combined neural stimulation to activate the paralyzed muscles and generate joint torques for limb movements with a controllable lower limb exoskeleton to stabilize and support the user. An onboard controller processed exoskeleton sensor signals, determined appropriate exoskeletal constraints and stimulation commands for a finite state machine (FSM), and transmitted data over Bluetooth to an off-board computer for real-time monitoring and data recording. The FSM coordinated stimulation and exoskeletal constraints to enable functions, selected with a wireless finger switch user interface, for standing up, standing, stepping, or sitting down. In the stepping function, the FSM used a sensor-based gait event detector to determine transitions between gait phases of double stance, early swing, late swing, and weight acceptance. RESULTS: The HNP restored stepping in three individuals with motor complete paralysis due to SCI. The controller appropriately coordinated stimulation and exoskeletal constraints using the sensor-based FSM for subjects with different stimulation systems. The average range of motion at hip and knee joints during walking were 8.5°-20.8° and 14.0°-43.6°, respectively. Walking speeds varied from 0.03 to 0.06 m/s, and cadences from 10 to 20 steps/min. CONCLUSIONS: A self-contained muscle-driven exoskeleton was a feasible intervention to restore stepping in individuals with paraplegia due to SCI. The untethered hybrid system was capable of adjusting to different individuals' needs to appropriately coordinate exoskeletal constraints with muscle activation using a sensor-driven FSM for stepping. Further improvements for out-of-the-laboratory use should include implantation of plantar flexor muscles to improve walking speed and power assist as needed at the hips and knees to maintain walking as muscles fatigue.

Feasibility of Restoring Walking in Multiple Sclerosis with Multichannel Implanted Electrical Stimulation.

A patient with multiple sclerosis-related gait dysfunction was followed over the course of his disease. Despite aggressive treatment, he developed significant weakness in ankle dorsiflexors and hip and knee flexors and was no longer capable of consistently taking a step on his own. With electrical stimulation of hip and knee flexors and ankle dorsiflexors using implanted electrodes, he was able to consistently walk short distances as far as 30 m, thus significantly improving his Expanded Disability Status Scale score. This case study supports further exploration into the potential benefits of an implanted pulse generator to ameliorate gait dysfunction and improve quality of life for people with multiple sclerosis.

Forward stair descent with hybrid neuroprosthesis after paralysis: Single case study demonstrating feasibility.

The ability to negotiate stairs is important for community access and independent mobility but requires more effort and strength than level walking. For this reason, previous attempts to utilize functional neuromuscular stimulation (FNS) to restore stair navigation after spinal cord injury (SCI) have had limited success and are not readily generalizable. Stair descent is particularly challenging because it requires energy absorption via eccentric muscle contractions, a task not easily accomplished with FNS. This article presents the design and initial testing of a hybrid neuroprosthesis with a variable impedance knee mechanism (VIKM-HNP) for stair descent. Using a 16-channel percutaneous FNS system, a muscle activation pattern was synthesized to descend stairs with the VIKM-HNP in a step-by-step fashion. A finite state control system was implemented to deactivate knee extensor stimulation and utilize the VIKM-HNP to absorb energy and regulate descent speed. Feasibility testing was performed on one individual with complete thoracic-level SCI. Stair descent was achieved with maximum upper-limb forces of less than 45% body weight compared with previously reported value of 70% with FNS only. The experiments also provided insight into design requirements for future hybrid systems for stair navigation, the implications of which are discussed.

Neurotherapeutic and neuroprosthetic effects of implanted functional electrical stimulation for ambulation after incomplete spinal cord injury.

The purpose of this single-subject study was to determine the neurotherapeutic and neuroprosthetic effects of an implanted functional electrical stimulation (FES) system designed to facilitate walking in an individual with a longstanding motor and sensory incomplete spinal cord injury. An implanted pulse generator and eight intramuscular stimulating electrodes were installed unilaterally, activating weak or paralyzed hip flexors, hip and knee extensors, and ankle dorsiflexors during 36 sessions of gait training with FES. The neurotherapeutic effects were assessed by a comparison of pre- and posttraining volitional walking. The neuroprosthetic effects were assessed by a comparison of posttraining volitional and FES-assisted walking. Treatment resulted in significant (p < 0.005) volitional improvements in 6-minute walking distance and speed, speed during maximum walk, double support time, and 10 m walking speed. Posttraining FES-assisted walking resulted in significant additional improvements in all these measures, except 10 m walking speed. When the subject was using FES-assisted gait, maximum walking distance, peak knee flexion in swing, peak ankle dorsiflexion in swing, and knee extension moment also significantly increased. Neuroprosthetic gains were sufficient to enable the subject to advance from household ambulation to limited community ambulation. Additionally, the subject could perform multiple walks per day when using FES-assisted gait, which was impossible with volitional effort alone.

Walking after incomplete spinal cord injury using an implanted FES system: a case report.

Implanted functional electrical stimulation (FES) systems for walking are experimentally available to individuals with incomplete spinal cord injury (SCI); however, data on short-term therapeutic and functional outcomes are limited. The goal of this study was to quantify therapeutic and functional effects of an implanted FES system for walking after incomplete cervical SCI. After robotic-assisted treadmill training and overground gait training maximized his voluntary function, an individual with incomplete SCI (American Spinal Injury Association grade C, cervical level 6-7) who could stand volitionally but not step was surgically implanted with an 8-channel receiver stimulator and intramuscular electrodes. Electrodes were implanted bilaterally, recruiting iliopsoas, vastus intermedius and lateralis, tensor fasciae latae, tibialis anterior, and peroneus longus muscles. Twelve weeks of training followed limited activity post-surgery. Customized stimulation patterns addressed gait deficits via an external control unit. The system was well-tolerated and reliable. After the 12-week training, maximal walking distance increased (from 14 m to 309 m), maximal walking speed was 10 times greater (from 0.02 m/s to 0.20 m/s), and physiological cost index was 5 times less (from 44.4 beats/m to 8.6 beats/m). Voluntary locomotor function was unchanged. The implanted FES system was well-tolerated, reliable, and supplemented function, allowing the participant limited community ambulation. Physiological effort decreased and maximal walking distance increased dramatically over 12 weeks.