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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., Competing Interests: Conflict of Interest The authors reported no conflict of interest., (Copyright © 2024 International Neuromodulation Society. All rights reserved.)

Over 50% of individuals with lower limb loss report a fear of falling and avoiding daily activities partly due to a lack of plantar sensation. Providing direct somatosensory feedback via neural stimulation holds promise for addressing this issue. In this study, three individuals with lower limb loss received a sensory neuroprosthesis (SNP) that provided plantar somatosensory feedback corresponding to prosthesis-floor interactions perceived as arising from the missing foot generated by electrically activating the peripheral nerves in the residuum. Participants walked on a treadmill while receiving perturbations involving brief increases in the belt speed. Perturbations were initiated during early stance and randomly delivered to intact and prosthetic sides with the SNP active or inactive. With the SNP active, participants exhibited decreased trunk angular sway and peak trunk flexion angular velocity during recovery from both prosthetic and intact side perturbations. For prosthetic side perturbations, peak ground reaction force magnitudes decreased when the SNP was active. For intact side perturbations, peak ground reaction force magnitudes increased on the prosthetic side's first recovery step after the perturbation, which resulted in a more symmetric recovery because the force approached the response on the intact side's first recovery step following a prosthetic side perturbation. These results suggest participants integrated the feedback from the SNP into their sensorimotor control for maintaining stability and gained confidence in relying on their prosthetic limb during recovery. Restoring plantar sensation with a SNP for individuals with lower limb loss could lead to reduced risk of falling by improving recovery from trips., Competing Interests: Declarations. Competing interests: The authors declare no competing interests., (© 2025. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Iterative Learning Control (ILC) is a promising method for adapting neuromuscular electrical stimulation to facilitate independent walking after upper motor neuron paralysis. However, assumptions made by conventional ILC methods, such as identical initial conditions for each iteration, are unsustainable in the case of human gait. In this study, we implement a musculoskeletal model of a single leg to analyze the consequences of variable initial conditions for data-driven ILC-based stimulation (DDILC) during swing phase of gait. We show that DDILC converges in all tested cases of initial hip angle variability, but that noise arises because of such variability. For the maximum variability case, the output with the largest noise (i.e., the terminal ankle angle) had a standard deviation of 2.1 degrees. Thus, the noise due to initial hip angle variability is shown to be comparable in magnitude to the inherent variability in gait. We also show that exploding gradients and instability eventually occur because of varying initial conditions, but these can be mitigated with established techniques.

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.

Injury or disease often compromise walking dynamics and negatively impact quality of life and independence. Assessing methods to restore or improve pathological gait can be expedited by examining a global parameter that reflects overall musculoskeletal control. Center of mass (CoM) kinematics follow well-defined trajectories during unimpaired gait, and change predictably with various gait pathologies. We propose a method to estimate CoM trajectories from inertial measurement units (IMUs) using a bidirectional Long Short-Term Memory neural network to evaluate rehabilitation interventions and outcomes. Five non-disabled volunteers participated in a single session of various dynamic walking trials with IMUs mounted on various body segments. A neural network trained with data from four of the five volunteers through a leave-one-subject out cross validation estimated the CoM with average root mean square errors (RMSEs) of 1.44cm, 1.15cm, and 0.40cm in the mediolateral (ML), anteroposterior (AP), and inferior/superior (IS) directions respectively. The impact of number and location of IMUs on network prediction accuracy was determined via principal component analysis. Comparing across all configurations, three to five IMUs located on the legs and medial trunk were the most promising reduced sensor sets for achieving CoM estimates suitable for outcome assessment. Lastly, the networks were tested on data from an individual with hemiparesis with the greatest error increase in the ML direction, which could stem from asymmetric gait. These results provide a framework for assessing gait deviations after disease or injury and evaluating rehabilitation interventions intended to normalize gait pathologies.

Spinal cord injury (SCI) can cause paralysis of trunk and hip musculature that negatively impacts seated balance and ability to lean away from an upright posture and interact fully with the environment. Constant levels of electrical stimulation of peripheral nerves can activate typically paralyzed muscles and aid in maintaining a single upright seated posture. However, in the absence of a feedback controller, such seated postures and leaning motions are inherently unstable and unable to respond to perturbations. Three individuals with motor complete SCI who had previously received a neuroprosthesis capable of activating the hip and trunk musculature volunteered for this study. Subject-specific muscle synergies were identified through system identification of the lumbar moments produced via neural stimulation. Synergy-based calculations determined the real-time stimulation parameters required to assume leaning postures. When combined with a proportional, integral, derivative (PID) feedback controller and an accelerometer to infer trunk orientation, all individuals were able to assume non-erect postures of 30-40° flexion and 15° lateral bending. Leaning postures increased forward reaching capabilities by 10.2, 46.7, and 16 cm respectively for each subject when compared with no stimulation. Additionally, the leaning controllers were able to resist perturbations of up to 90 N, and all subjects perceived the leaning postures as moderately to very stable. Implementation of leaning controllers for neuroprostheses have the potential of expanding workspaces, increasing independence, and facilitating activities of daily living for individuals with paralysis., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Friederich, Lombardo, Foglyano, Audu and Triolo.)

Introduction: Individuals with lower limb loss experience an increased risk of falls partly due to the lack of sensory feedback from their missing foot. It is possible to restore plantar sensation perceived as originating from the missing foot by directly interfacing with the peripheral nerves remaining in the residual limb, which in turn has shown promise in improving gait and balance. However, it is yet unclear how these electrically elicited plantar sensation are integrated into the body's natural sensorimotor control reflexes. Historically, the H-reflex has been used as a model for investigating sensorimotor control. Within the spinal cord, an array of inputs, including plantar cutaneous sensation, are integrated to produce inhibitory and excitatory effects on the H-reflex., Methods: In this study, we characterized the interplay between electrically elicited plantar sensations and this intrinsic reflex mechanism. Participants adopted postures mimicking specific phases of the gait cycle. During each posture, we electrically elicited plantar sensation, and subsequently the H-reflex was evoked both in the presence and absence of these sensations., Results: Our findings indicated that electrically elicited plantar sensations did not significantly alter the H-reflex excitability across any of the adopted postures., Conclusion: This suggests that individuals with lower limb loss can directly benefit from electrically elicited plantar sensation during walking without disrupting the existing sensory signaling pathways that modulate reflex responses., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential competing interest., (Copyright © 2023 Li, Triolo and Charkhkar.)

Introduction: Lower limb prosthesis users often struggle to navigate uneven terrain or ambulate in low light conditions where it can be challenging to rely on visual cues for balance and walking. Sensory feedback about foot-floor interactions may allow users to reduce reliance on secondary sensory cues and improve confidence and speed when navigating difficult terrain. Our group has developed a Sensory Neuroprosthesis (SNP) to restore sensation to people with lower limb amputation by pairing electrical stimulation of nerves in the residual limb applied via implanted neurotechnology with pressure sensors in the insole of a standard prosthesis. Stimulation applied to the nerves evoked sensations perceived as originating on the missing leg and foot., Methods: This qualitative case study reports on the experiences of a 68-year-old with a unilateral trans-tibial amputation who autonomously used the SNP at home for 31 weeks. Interview data collected throughout the study period was analyzed using a grounded theory approach with constant comparative methods to understand his experience with this novel technology and its impacts on his daily life., Results: A conceptual model was developed that explained the experience of integrating SNP-provided sensory feedback into his body and motor plans. The model described the requirements of integration, which were a combination of a low level of mental focus and low stimulation levels. While higher levels of stimulation and focus could result in distinct sensory percepts and various phantom limb experiences, optimal integration was associated with SNP-evoked sensation that was not readily perceivable. Successful sensorimotor integration of the SNP resulted in improvements to locomotion, a return to a more normal state, an enhancement of perceived prosthesis utility, and a positive outlook on the experience., Discussion: These outcomes emerged over the course of the nearly 8 month study, suggesting that findings from long-term home studies of SNPs may differ from those of short-term in-laboratory tests. Our findings on the experience of sensorimotor integration of the SNP have implications for the optimal training of SNP users and the future deployment of clinical SNP systems for long-term home use., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Schmitt, Wright, Triolo, Charkhkar and Graczyk.)

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., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

A two-part simulation process was developed to investigate the facilitation of vertical patient lifts with functional neuromuscular stimulation (FNS) in individuals with spinal cord injury (SCI). First, external lifting forces representing caregiver assistance were applied to a 3D musculoskeletal model representing the patient and optimized to enforce a specific lifting trajectory during a forward dynamic simulation. The process was repeated with and without the activation of the knee, hip, and trunk extensor muscles of the patient model to represent contractions of the paralyzed muscles generated via FNS. Secondly, the spinal compression experienced by a caregiver at the L5/S1 joint while generating these external lifting forces was estimated using a second musculoskeletal model representing the caregiver. Simulation without muscle activation predicted spinal compression in the caregiver model approximately 1.3 × the National Institute for Occupational Safety and Health (NIOSH) recommended "Action Limit." Comparatively, simulations with two unique patterns of muscle activation both predicted caregiver spinal compressions below NIOSH recommendations. These simulation results support the hypothesis that FNS activation of a patient's otherwise paralyzed muscles would lower the force output required of a caregiver during a dependent transfer, thus lowering the spinal compression and risk of injury experienced by a caregiver., (© 2022. International Federation for Medical and Biological Engineering.)

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.

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., (Copyright © 2022 by ASME.)

Objective: Wheelchair safety is of great importance since falls from wheelchairs are prevalent and often have devastating consequences. We developed an automatic system to detect destabilizing events during wheelchair propulsion under real-world conditions and trigger neural stimulation to stiffen the trunk to maintain seated postures of users with paralysis. Design: Cross-over intervention Setting: Laboratory and community settings Participants: Three able-bodied subjects and three individuals with SCI with previously implanted neurostimulation systems Interventions: An algorithm to detect wheelchair sudden stops was developed. This was used to randomly trigger trunk extensor stimulation during sudden stops events Outcome Measures: Algorithm success and false positive rates were determined. SCI users rated each condition on a seven-point Usability Rating Scale to indicate safety. Results: The system detected sudden stops with a success rate of over 93% in community settings. When used to trigger trunk neurostimulation to ensure stability, the implant recipients consistently reported feeling safer ( P <.05 for 2/3 subjects) with the system while encountering sudden stops as indicated by a 1-3 point change in safety rating. Conclusion: These preliminary results suggest that this system could monitor wheelchair activity and only apply stabilizing neurostimulation when appropriate to maintain posture. Larger scale, unsupervised and longer-term trials at home and in the community are indicated. This system could be generalized and applied to individuals without an implanted stimulation by utilizing surface stimulation, or by actuating a mechanical restraint when necessary, thus allowing unrestricted trunk movements and only restraining the user when necessary to ensure safety. Trial Registration: NCT01474148.