Anatomical Registration of Implanted Sensors Improves Accuracy of Trunk Tilt Estimates with a Networked Neuroprosthesis.

For individuals with spinal cord injuries (SCIs) above the midthoracic level, a common complication is the partial or complete loss of trunk stability in the seated position. Functional neuromuscular stimulation (FNS) can restore seated posture and other motor functions after paralysis by applying small electrical currents to the peripheral motor nerves. In particular, the Networked Neuroprosthesis (NNP) is a fully implanted, modular FNS system that is also capable of capturing information from embedded accelerometers for measuring trunk tilt for feedback control of stimulation. The NNP modules containing the accelerometers are located in the body based on surgical constraints. As such, their exact orientations are generally unknown and cannot be easily assessed. In this study, a method for estimating trunk tilt that employed the Gram-Schmidt method to reorient acceleration signals to the anatomical axes of the body was developed and deployed in individuals with SCI using the implanted NNP system. An anatomically realistic model of a human trunk and five accelerometer sensors was developed to verify the accuracy of the reorientation algorithm. Correlation coefficients and root mean square errors (RMSEs) were calculated to compare target trunk tilt estimates and tilt estimates derived from simulated accelerometer signals under a variety of conditions. Simulated trunk tilt estimates with correlation coefficients above 0.92 and RMSEs below 5° were achieved. The algorithm was then applied to accelerometer signals from implanted sensors installed in three NNP recipients. Error analysis was performed by comparing the correlation coefficients and RMSEs derived from trunk tilt estimates calculated from implanted sensor signals to those calculated via motion capture data, which served as the gold standard. NNP-derived trunk tilt estimates exhibited correlation coefficients between 0.80 and 0.95 and RMSEs below 13° for both pitch and roll in most cases. These findings suggest that the algorithm is effective at estimating trunk tilt with the implanted sensors of the NNP system, which implies that the method may be appropriate for extracting feedback signals for control systems for seated stability with NNP technology for individuals who have reduced control of their trunk due to paralysis.

Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review.

OBJECTIVES: Neuroprosthetic devices can improve quality of life by providing an alternative option for motor function lost after spinal cord injury, stroke, and other central nervous system disorders. The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis to assist with lower extremity function over a 25-year period, specifically, to determine survival rates and common modes of malfunction, reasons for removal or revision, and precipitating factors or external events that may have adversely influenced device performance. MATERIALS AND METHODS: Our implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12 and IST-16) device histories were retrospectively reviewed through surgical notes, regulatory documentation, and manufacturing records from 1996 to 2021. RESULTS: Most of the 65 devices (64.6%) implanted in 43 volunteers remain implanted and operational. Seven underwent explantation owing to infection; seven had internal failures, and six were physically broken by external events. Of the 22 devices explanted, 15 were successfully replaced to restore recipients' enhanced functionality. There were no instances of sepsis or major health complications. The five infections that followed all 93 IRS and IST lower extremity research surgeries during this period indicate a pooled infection rate of 5.4%. The Kaplan-Meier analysis of technical malfunctions between the implant date and most recent follow-up shows five-, ten-, and 20-year device survival rates of 92%, 84%, and 71%, respectively. CONCLUSIONS: Incidence of malfunction is similar to, whereas infection rates are slightly higher than, other commonly implanted medical devices. Future investigations will focus on infection prevention, modifying techniques on the basis of recipient demographics, lifestyle factors, and education, and integrating similar experience of motor neuroprostheses used in other applications.

Evaluation of Power Wheelchair Dynamic Suspensions for Tip Prevention in Non-ADA Compliant Surfaces.

OBJECTIVE: To evaluate the driving performance and usability of a mobility enhancement robot (MEBot) wheelchair with 2 innovative dynamic suspensions compared with commercial electric powered wheelchair (EPW) suspensions on non-American with Disabilities Act (ADA) compliant surfaces. The 2 dynamic suspensions used pneumatic actuators (PA) and electro-hydraulic with springs in series electrohydraulic and spring in series (EHAS). DESIGN: Within-subjects cross-sectional study. Driving performance and usability were evaluated using quantitative measures and standardized tools, respectively. SETTING: Laboratory settings that simulated common EPW outdoor driving tasks. PARTICIPANTS: 10 EPW users (5 women, 5 men) with an average age of 53.9±11.5 years and 21.2±16.3 years of EPW driving experience (N=10). INTERVENTION: Not applicable. MAIN OUTCOME MEASURE(S): Seat angle peaks (stability), number of completed trials (effectiveness), Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST), and systemic usability scale (SUS). RESULTS: MEBot with dynamic suspensions demonstrated significantly better stability (all P<.001) than EPW passive suspensions on non-ADA-compliant surfaces by reducing seat angle changes (safety). Also, MEBot with EHAS suspension significantly completed more trials over potholes compared with MEBot with PA suspension (P<.001) and EPW suspensions (P<.001). MEBot with EHAS had significantly better scores in terms of ease of adjustment (P=.016), durability (P=.031), and usability (P=.032) compared with MEBot with PA suspension on all surfaces. Physical assistance was required to navigate over potholes using MEBot with PA suspension and EPW suspensions. Also, participants reported similar responses regarding ease of use and satisfaction toward MEBot with EHAS suspension and EPW suspensions. CONCLUSIONS: MEBot with dynamic suspensions improve safety and stability when navigating non-ADA-compliant surfaces compared with commercial EPW passive suspensions. Findings indicate MEBot readiness for further evaluation in real-world environments.

Robust Control of the Human Trunk Posture Using Functional Neuromuscular Stimulation: A Simulation Study.

The trunk movements of an individual paralyzed by spinal cord injury (SCI) can be restored by functional neuromuscular stimulation (FNS), which applies low-level current to the motor nerves to activate the paralyzed muscles to generate useful torques, to actuate the trunk. FNS can be modulated to vary the biotorques to drive the trunk to follow a user-defined reference motion and maintain it at a desired postural set-point. However, a stabilizing modulation policy (i.e., control law) is difficult to derive as the biomechanics of the spine and pelvis are complex and the neuromuscular dynamics are highly nonlinear, nonautonomous, and input redundant. Therefore, a control method that can stabilize it with FNS without knowing the accurate skeletal and neuromuscular dynamics is desired. To achieve this goal, we propose a control framework consisting of a robust control module that generates stabilizing torques while an artificial neural network-based mapping mechanism with an anatomy-based updating law ensures that the muscle-generated torques converge to the stabilizing values. For the robust control module, two sliding-mode robust controllers (i.e., a high compensation controller and an adaptive controller), were investigated. System stability of the proposed control method was rigorously analyzed based on the assumption that the skeletal dynamics can be approximated by Euler-Lagrange equations with bounded disturbances, which enables the generalization of the control framework. We present experiments in a simulation environment where an anatomically realistic three-dimensional musculoskeletal model of the human trunk moved in the anterior- posterior and medial-lateral directions while perturbations were applied. The satisfactory simulation results suggest the potential of this control technique for trunk tracking tasks in a typical clinical environment.

Feedback control of upright seating with functional neuromuscular stimulation during a reaching task after spinal cord injury: a feasibility study.

BACKGROUND: Restoring or improving seated stability after spinal cord injury (SCI) can improve the ability to perform activities of daily living by providing a dynamic, yet stable, base for upper extremity motion. Seated stability can be obtained with activation of the otherwise paralyzed trunk and hip musculature with neural stimulation, which has been shown to extend upper limb reach and improve seated posture. METHODS: We implemented a proportional, integral, derivative (PID) controller to maintain upright seated posture by simultaneously modulating both forward flexion and lateral bending with functional neuromuscular stimulation. The controller was tested with a functional reaching task meant to require trunk movements and impart internal perturbations through rapid changes in inertia due to acquiring, moving, and replacing objects with one upper extremity. Five subjects with SCI at various injury levels who had received implanted stimulators targeting their trunk and hip muscles participated in the study. Each subject was asked to move a weighted jar radially from a center home station to one of three target stations. The task was performed with the controller active, inactive, or with a constant low level of neural stimulation. Trunk pitch (flexion) and roll (lateral bending) angles were measured with motion capture and plotted against each other to generate elliptical movement profiles for each task and condition. Postural sway was quantified by calculating the ellipse area. Additionally, the mean effective reach (distance between the shoulder and wrist) and the time required to return to an upright posture was determined during reaching movements. RESULTS: Postural sway was reduced by the controller in two of the subjects, and mean effective reach was increased in three subjects and decreased for one. Analysis of the major direction of motion showed return to upright movements were quickened by 0.17 to 0.32 s. A 15 to 25% improvement over low/no stimulation was observed for four subjects. CONCLUSION: These results suggest that feedback control of neural stimulation is a viable way to maintain upright seated posture by facilitating trunk movements necessary to complete reaching tasks in individuals with SCI. Replication of these findings on a larger number of subjects would be necessary for generalization to the various segments of the SCI population.

Motorless cadence control of standard and low duty cycle-patterned neural stimulation intensity extends muscle-driven cycling output after paralysis.

BACKGROUND: Stimulation-driven exercise is often limited by rapid fatigue of the activated muscles. Selective neural stimulation patterns that decrease activated fiber overlap and/or duty cycle improve cycling exercise duration and intensity. However, unequal outputs from independently activated fiber populations may cause large discrepancies in power production and crank angle velocity among pedal revolutions. Enforcing a constant cadence through feedback control of stimulus levels may address this issue and further improve endurance by targeting a submaximal but higher than steady-state exercise intensity. METHODS: Seven participants with paralysis cycled using standard cadence-controlled stimulation (S-Cont). Four of those participants also cycled with a low duty cycle (carousel) cadence-controlled stimulation scheme (C-Cont). S-Cont and C-Cont patterns were compared with conventional maximal stimulation (S-Max). Outcome measures include total work (W), end power (Pend), power fluctuation (PFI), charge accumulation (Q) and efficiency (η). Physiological measurements of muscle oxygenation (SmO2) and heart rate were also collected with select participants. RESULTS: At least one cadence-controlled stimulation pattern (S-Cont or C-Cont) improved Pend over S-Max in all participants and increased W in three participants. Both controlled patterns increased Q and η and reduced PFI compared with S-Max and prior open-loop studies. S-Cont stimulation also delayed declines in SmO2 and increased heart rate in one participant compared with S-Max. CONCLUSIONS: Cadence-controlled selective stimulation improves cycling endurance and increases efficiency over conventional stimulation by incorporating fiber groups only as needed to maintain a desired exercise intensity. Closed-loop carousel stimulation also successfully reduces power fluctuations relative to previous open-loop efforts, which will enable neuroprosthesis recipients to better take advantage of duty cycle reducing patterns.

Trunk Posture from Randomly Oriented Accelerometers.

Feedback control of functional neuromuscular stimulation has the potential to improve daily function for individuals with spinal cord injuries (SCIs) by enhancing seated stability. Our fully implanted networked neuroprosthesis (NNP) can provide real-time feedback signals for controlling the trunk through accelerometers embedded in modules distributed throughout the trunk. Typically, inertial sensors are aligned with the relevant body segment. However, NNP implanted modules are placed according to surgical constraints and their precise locations and orientations are generally unknown. We have developed a method for calibrating multiple randomly oriented accelerometers and fusing their signals into a measure of trunk orientation. Six accelerometers were externally attached in random orientations to the trunks of six individuals with SCI. Calibration with an optical motion capture system resulted in RMSE below 5° and correlation coefficients above 0.97. Calibration with a handheld goniometer resulted in RMSE of 7° and correlation coefficients above 0.93. Our method can obtain trunk orientation from a network of sensors without a priori knowledge of their relationships to the body anatomical axes. The results of this study will be invaluable in the design of feedback control systems for stabilizing the trunk of individuals with SCI in combination with the NNP implanted technology.

Selective neural stimulation methods improve cycling exercise performance after spinal cord injury: a case series.

BACKGROUND: Exercise after paralysis can help prevent secondary health complications, but achieving adequate exercise volumes and intensities is difficult with loss of motor control. Existing electrical stimulation-driven cycling systems involve the paralyzed musculature but result in rapid force decline and muscle fatigue, limiting their effectiveness. This study explores the effects of selective stimulation patterns delivered through multi-contact nerve cuff electrodes on functional exercise output, with the goal of increasing work performed and power maintained within each bout of exercise. METHODS: Three people with spinal cord injury and implanted stimulation systems performed cycling trials using conventional (S-Max), low overlap (S-Low), low duty cycle (C-Max), and/or combined low overlap and low duty cycle (C-Low) stimulation patterns. Outcome measures include total work (W), end power (Pend), power fluctuation indices (PFI), charge accumulation (Q), and efficiency (η). Mann-Whitney tests were used for statistical comparisons of W and Pend between a selective pattern and S-Max. Welch's ANOVAs were used to evaluate differences in PFIs among all patterns tested within a participant (n ≥ 90 per stimulation condition). RESULTS: At least one selective pattern significantly (p < 0.05) increased W and Pend over S-Max in each participant. All selective patterns also reduced Q and increased η compared with S-Max for all participants. C-Max significantly (p < 0.01) increased PFI, indicating a decrease in ride smoothness with low duty cycle patterns. CONCLUSIONS: Selective stimulation patterns can increase work performed and power sustained by paralyzed muscles prior to fatigue with increased stimulation efficiency. While still effective, low duty cycle patterns can cause inconsistent power outputs each pedal stroke, but this can be managed by utilizing optimized stimulation levels. Increasing work and sustained power each exercise session has the potential to ultimately improve the physiological benefits of stimulation-driven exercise.

Estimating Center of Mass Kinematics During Perturbed Human Standing Using Accelerometers.

Estimating center of mass (COM) through sensor measurements is done to maintain walking and standing stability with exoskeletons. The authors present a method for estimating COM kinematics through an artificial neural network, which was trained by minimizing the mean squared error between COM displacements measured by a gold-standard motion capture system and recorded acceleration signals from body-mounted accelerometers. A total of 5 able-bodied participants were destabilized during standing through: (1) unexpected perturbations caused by 4 linear actuators pulling on the waist and (2) volitionally moving weighted jars on a shelf. Each movement type was averaged across all participants. The algorithm's performance was quantified by the root mean square error and coefficient of determination (R2) calculated from both the entire trial and during each perturbation type. Throughout the trials and movement types, the average coefficient of determination was 0.83, with 89% of the movements with R2 > .70, while the average root mean square error ranged between 7.3% and 22.0%, corresponding to 0.5- and 0.94-cm error in both the coronal and sagittal planes. COM can be estimated in real time for balance control of exoskeletons for individuals with a spinal cord injury, and the procedure can be generalized for other gait studies.

Sum of phase-shifted sinusoids stimulation prolongs paralyzed muscle output.

Neuroprostheses that activate musculature of the lower extremities can enable standing and movement after paralysis. Current systems are functionally limited by rapid muscle fatigue induced by conventional, non-varying stimulus waveforms. Previous work has shown that sum of phase-shifted sinusoids (SOPS) stimulation, which selectively modulates activation of individual motor unit pools (MUPs) to lower the duty cycle of each while maintaining a high net muscle output, improves joint moment maintenance but introduces greater instability over conventional stimulation. In this case study, implementation of SOPS stimulation with a real-time feedback controller successfully decreased joint moment instability and further prolonged joint moment output with increased stimulation efficiency over open-loop approaches in one participant with spinal cord injury. These findings demonstrate the potential for closed-loop SOPS to improve functionality of neuroprosthetic systems.

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.

Implanted High Density Cuff Electrodes Functionally Activate Human Tibial and Peroneal Motor Units Without Chronic Detriment to Peripheral Nerve Health.

OBJECTIVE: Peripheral nerve stimulation via multi-contact nerve cuff electrodes (NCEs) has proved effective in restoring function to individuals with lower-extremity paralysis. This study investigates clinical measures of nerve health over one year post-implantation of a composite flat-interface nerve electrode (C-FINE) on the tibial and peroneal nerves above the knee in a human volunteer. This represents the first deployment of a novel NCE on new neural targets in a uniquely challenging location prone to prolonged externally applied forces, making acute and chronic postoperative observation critical. MATERIALS AND METHODS: A 27-year-old man with an incomplete spinal cord injury (AIS C) at the C3 to C4 level received eight-contact C-FINEs bilaterally on the tibial and peroneal nerves, proximal to the knee. Access to four contacts per cuff exhibiting the most desirable responses was externalized via temporary percutaneous leads. Percutaneous leads were later removed, with contacts generating the best dorsiflexion (two of four) and plantar flexion (one of four) reconnected to a permanently implanted pulse generator. For 13 months post-implantation, nerve health and cuff performance were assessed through motor nerve conduction velocity (MNCV) studies, clinical needle electromyography, compound motor action potential (CMAP), sensory nerve action potential (SNAP), stimulation-evoked tetanic moment collection, and lower-limb circumference measurements. RESULTS: Tibial and peroneal MNCVs remained stable bilaterally above 40 m/sec, with CMAPs increased or stable after six months. SNAPs remained stable across all measurements. CMAP initial charge thresholds remained below 50 nC, with minimal changes to muscle recruitment order in three of four externalized contacts per cuff. Peak tetanic moments remained stable, with bilateral increases in thigh and calf circumferences of 5% and 14% over one year. CONCLUSIONS: Above-knee tibial and peroneal NCEs can restore stimulated ankle-joint function without chronic nerve health detriments. Alongside previous femoral nerve data, this study demonstrates the ability of NCEs to enhance lower-extremity function with limited neuromuscular impact.

Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up.

OBJECTIVE: To quantify the long-term (>2y) effects of lower extremity (LE) neuroprostheses (NPs) for standing, transfers, stepping, and seated stability after spinal cord injury. DESIGN: Single-subject design case series with participants acting as their own concurrent controls, including retrospective data review. SETTING: Hospital-based clinical biomechanics laboratory with experienced (>20y in the field) research biomedical engineers, a physical therapist, and medical monitoring review. PARTICIPANTS: Long-term (6.2±2.7y) at-home users (N=22; 19 men, 3 women) of implanted NPs for trunk and LE function with chronic (14.4±7.1y) spinal cord injury resulting in full or partial paralysis. INTERVENTIONS: Technical and clinical performance measurements, along with user satisfaction surveys. MAIN OUTCOME MEASURES: Knee extension moment, maximum standing time, body weight supported by lower extremities, 3 functional standing tasks, 2 satisfaction surveys, NP usage, and stability of implanted components. RESULTS: Stimulated knee extension strength and functional capabilities were maintained, with 94% of implant recipients reporting being very or moderately satisfied with their system. More than half (60%) of the participants were still using their implanted NPs for exercise and function for >10min/d on nearly half or more of the days monitored; however, maximum standing times and percentage body weight through LEs decreased slightly over the follow-up interval. Stimulus thresholds were uniformly stable. Six-year survival rates for the first-generation implanted pulse generator (IPG) and epimysial electrodes were close to 90%, whereas those for the second-generation IPG along with the intramuscular and nerve cuff electrodes were >98%. CONCLUSIONS: Objective and subjective measures of the technical and clinical performances of implanted LE NPs generally remained consistent for 22 participants after an average of 6 years of unsupervised use at home. These findings suggest that implanted LE NPs can provide lasting benefits that recipients value.

Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events.

BACKGROUND: The leading cause of injury for manual wheelchair users are tips and falls caused by unexpected destabilizing events encountered during everyday activities. The purpose of this study was to determine the feasibility of automatically restoring seated stability to manual wheelchair users with spinal cord injury (SCI) via a threshold-based system to activate the hip and trunk muscles with electrical stimulation during potentially destabilizing events. METHODS: We detected and classified potentially destabilizing sudden stops and turns with a wheelchair-mounted wireless inertial measurement unit (IMU), and then applied neural stimulation to activate the appropriate muscles to resist trunk movement and restore seated stability. After modeling and preliminary testing to determine the appropriate inertial signatures to discriminate between events and reliably trigger stimulation, the system was implemented and evaluated in real-time on manual wheelchair users with SCI. Three participants completed simulated collision events and four participants completed simulated rapid turns. Data were analyzed as a series of individual case studies with subjects acting as their own controls with and without the system active. RESULTS: The controller achieved 93% accuracy in detecting collisions and right turns, and 100% accuracy in left turn detection. Two of the three subjects who participated in collision testing with stimulation experienced significantly decreased maximum anterior-posterior trunk angles (p < 0.05). Similar results were obtained with implanted and surface stimulation systems. CONCLUSIONS: This study demonstrates the feasibility of a neural stimulation control system based on simple inertial measurements to improve trunk stability and overall safety of people with spinal cord injuries during manual wheelchair propulsion. Further studies are required to determine clinical utility in real world situations and generalizability to the broader SCI or other population of manual or powered wheelchair users. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01474148 . Registered 11/08/2011 retrospectively registered.

Setting the pace: insights and advancements gained while preparing for an FES bike race.

The reduction in physical activity following a spinal cord injury often leads to a decline in mental and physical health. Developing an exercise program that is effective and enjoyable is paramount for this population. Although functional electrical stimulation (FES) stationary cycling has been utilized in rehabilitation settings, implementing an overground cycling program for those with spinal cord injuries has greater technical challenges. Recently our laboratory team focused on training five individuals with compete spinal cord injuries utilizing an implanted pulse generator for an overground FES bike race in CYBATHLON 2016 held in Zurich, Switzerland. The advancements in muscle strength and endurance and ultimately cycling power our pilots made during this training period not only helped propel our competing pilot to win gold at the CYBATHLON 2016, but allowed our pilots to ride their bikes outside within their communities. Such a positive outcome has encouraged us to put effort into developing more widespread use of FES overground cycling as a rehabilitative tool for those with spinal cord injuries. This commentary will describe our approach to the CYBATHLON 2016 including technological advancements, bike design and the training program.

Reactive stepping with functional neuromuscular stimulation in response to forward-directed perturbations.

BACKGROUND: Implanted motor system neuroprostheses can be effective at increasing personal mobility of persons paralyzed by spinal cord injuries. However, currently available neural stimulation systems for standing employ patterns of constant activation and are unreactive to changing postural demands. METHODS: In this work, we developed a closed-loop controller for detecting forward-directed body disturbances and initiating a stabilizing step in a person with spinal cord injury. Forward-directed pulls at the waist were detected with three body-mounted triaxial accelerometers. A finite state machine was designed and tested to trigger a postural response and apply stimulation to appropriate muscles so as to produce a protective step when the simplified jerk signal exceeded predetermined thresholds. RESULTS: The controller effectively initiated steps for all perturbations with magnitude between 10 and 17.5 s body weight, and initiated a postural response with occasional steps at 5% body weight. For perturbations at 15 and 17.5% body weight, the dynamic responses of the subject exhibited very similar component time periods when compared with able-bodied subjects undergoing similar postural perturbations. Additionally, the reactive step occurred faster for stronger perturbations than for weaker ones (p < .005, unequal varience t-test.) CONCLUSIONS: This research marks progress towards a controller which can improve the safety and independence of persons with spinal cord injury using implanted neuroprostheses for standing.

"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.

Improving stand-to-sit maneuver for individuals with spinal cord injury.

BACKGROUND: Users of neuroprostheses employing electrical stimulation (ES) generally complete the stand-to-sit (STS) maneuver with high knee angular velocities, increased upper limb support forces, and high peak impact forces at initial contact with the chair. Controlling the knee during STS descent is challenging in individuals with spinal cord injury (SCI) due to the decreasing joint moment available with increased knee angle in response to ES. METHODS: The goal of this study was to investigate the effects of incorporating either (1) a coupling mechanism that coordinates hip and knee flexion or (2) a mechanism that damps knee motion to keep the knee angular velocity constant during the STS transition. The coupling and damping were achieved by hydraulic orthotic mechanisms. Two subjects with SCI were enrolled and each served as their own controls when characterizing the performance of each mechanism during STS as compared to stimulation alone. Outcome measures such as hip-knee angle, knee angular velocity, upper limb support force, and impact force were analyzed to determine the effectiveness of the two mechanisms in providing controlled STS. RESULTS: The coordination between the hip and knee joints improved with each orthotic mechanism. The damping and hip-knee coupling mechanisms caused the hip and knee joint ratios of 1:1.1 and 1:0.99, respectively, which approached the 1:1 coordination ratio observed in nondisabled individuals during STS maneuver. The knee damping mechanism provided lower (p < 0.001) and a more constant knee angular velocity than the hip-knee coupling mechanism over the knee range of motion. Both the coupling and damping mechanisms were similarly effective at reducing upper limb support forces by 70 % (p < 0.001) and impact force by half (p ≤ 0.001) as compared to sitting down with stimulation alone. CONCLUSIONS: Orthoses imposing simple kinematic constraints, such as 1:1 hip-knee coupling or knee damping, can normalize upper limb support forces, peak knee angular velocity, and peak impact force during the STS maneuvers.

A neuroprosthesis for control of seated balance after spinal cord injury.

BACKGROUND: A major desire of individuals with spinal cord injury (SCI) is the ability to maintain a stable trunk while in a seated position. Such stability is invaluable during many activities of daily living (ADL) such as regular work in the home and office environments, wheelchair propulsion and driving a vehicle. Functional neuromuscular stimulation (FNS) has the ability to restore function to paralyzed muscles by application of measured low-level currents to the nerves serving those muscles. METHODS: A feedback control system for maintaining seated balance under external perturbations was designed and tested in individuals with thoracic and cervical level spinal cord injuries. The control system relied on a signal related to the tilt of the trunk from the vertical position (which varied between 1.0 ≡ erect posture and 0.0 ≡ most forward flexed posture) derived from a sensor fixed to the sternum to activate the user's own hip and trunk extensor muscles via an implanted neuroprosthesis. A proportional-derivative controller modulated stimulation between trunk tilt values indicating deviation from the erect posture and maximum desired forward flexion. Tests were carried out with external perturbation forces set at 35%, 40% and 45% body-weight (BW) and maximal forward trunk tilt flexion thresholds set at 0.85, 0.75 and 0.70. RESULTS: Preliminary tests in a case series of five subjects show that the controller could maintain trunk stability in the sagittal plane for perturbations up to 45% of body weight and for flexion thresholds as low as 0.7. The mean settling time varied across subjects from 0.5(±0.4) and 2.0 (±1.1) seconds. Mean response time of the feedback control system varied from 393(±38) ms and 536(±84) ms across the cohort. CONCLUSIONS: The results show the high potential for robust control of seated balance against nominal perturbations in individuals with spinal cord injury and indicates that trunk control with FNS is a promising intervention for individuals with SCI.