Feasibility of a Wireless Implantable Multi-electrode System for High-bandwidth Prosthetic Interfacing: Animal and Cadaver Study.

BACKGROUND: Currently used prosthetic solutions in upper extremity amputation have limited functionality, owing to low information transfer rates of neuromuscular interfacing. Although surgical innovations have expanded the functional potential of the residual limb, available interfaces are inefficacious in translating this potential into improved prosthetic control. There is currently no implantable solution for functional interfacing in extremity amputation which offers long-term stability, high information transfer rates, and is applicable for all levels of limb loss. In this study, we presented a novel neuromuscular implant, the the Myoelectric Implantable Recording Array (MIRA). To our knowledge, it is the first fully implantable system for prosthetic interfacing with a large channel count, comprising 32 intramuscular electrodes. QUESTIONS/PURPOSES: The purpose of this study was to evaluate the MIRA in terms of biocompatibility, functionality, and feasibility of implantation to lay the foundations for clinical application. This was achieved through small- and large-animal studies as well as test surgeries in a human cadaver. METHODS: We evaluated the biocompatibility of the system's intramuscular electromyography (EMG) leads in a rabbit model. Ten leads as well as 10 pieces of a biologically inert control material were implanted into the paravertebral muscles of four animals. After a 3-month implantation, tissue samples were taken and histopathological assessment performed. The probes were scored according to a protocol for the assessment of the foreign body response, with primary endpoints being inflammation score, tissue response score, and capsule thickness in µm. In a second study, chronic functionality of the full system was evaluated in large animals. The MIRA was implanted into the shoulder region of six dogs and three sheep, with intramuscular leads distributed across agonist and antagonist muscles of shoulder flexion. During the observation period, regular EMG measurements were performed. The implants were removed after 5 to 6 months except for one animal, which retained the implant for prolonged observation. Primary endpoints of the large-animal study were mechanical stability, telemetric capability, and EMG signal quality. A final study involved the development of test surgeries in a fresh human cadaver, with the goal to determine feasibility to implant relevant target muscles for prosthetic control at all levels of major upper limb amputation. RESULTS: Evaluation of the foreign body reaction revealed favorable biocompatibility and a low-grade tissue response in the rabbit study. No differences regarding inflammation score (EMG 4.60 ± 0.97 [95% CI 4.00 to 5.20] versus control 4.20 ± 1.48 [95% CI 3.29 to 5.11]; p = 0.51), tissue response score (EMG 4.00 ± 0.82 [95% CI 3.49 to 4.51] versus control 4.00 ± 0.94 [95% CI 3.42 to 4.58]; p > 0.99), or thickness of capsule (EMG 19.00 ± 8.76 µm [95% CI 13.57 to 24.43] versus control 29.00 ± 23.31 µm [95% CI 14.55 to 43.45]; p = 0.29) were found compared with the inert control article (high-density polyethylene) after 3 months of intramuscular implantation. Throughout long-term implantation of the MIRA in large animals, telemetric communication remained unrestricted in all specimens. Further, the implants retained the ability to record and transmit intramuscular EMG data in all animals except for two sheep where the implants became dislocated shortly after implantation. Electrode impedances remained stable and below 5 kΩ. Regarding EMG signal quality, there was little crosstalk between muscles and overall average signal-to-noise ratio was 22.2 ± 6.2 dB. During the test surgeries, we found that it was possible to implant the MIRA at all major amputation levels of the upper limb in a human cadaver (the transradial, transhumeral, and glenohumeral levels). For each level, it was possible to place the central unit in a biomechanically stable environment to provide unhindered telemetry, while reaching the relevant target muscles for prosthetic control. At only the glenohumeral level, it was not possible to reach the teres major and latissimus dorsi muscles, which would require longer lead lengths. CONCLUSION: As assessed in a combination of animal model and cadaver research, the MIRA shows promise for clinical research in patients with limb amputation, where it may be employed for all levels of major upper limb amputation to provide long-term stable intramuscular EMG transmission. CLINICAL RELEVANCE: In our study, the MIRA provided high-bandwidth prosthetic interfacing through intramuscular electrode sites. Its high number of individual EMG channels may be combined with signal decoding algorithms for accessing spinal motor neuron activity after targeted muscle reinnervation, thus providing numerous degrees of freedom. Together with recent innovations in amputation surgery, the MIRA might enable improved control approaches for upper limb amputees, particularly for patients with above-elbow amputation where the mismatch between available control signals and necessary degrees of freedom for prosthetic control is highest.

Ultra-Low-Power Digital Filtering for Insulated EMG Sensing.

Myoelectric prostheses help amputees to regain independence and a higher quality of life. These prostheses are controlled by state-of-the-art electromyography sensors, which use a conductive connection to the skin and are therefore sensitive to sweat. They are applied with some pressure to ensure a conductive connection, which may result in pressure marks and can be problematic for patients with circulatory disorders, who constitute a major group of amputees. Here, we present ultra-low-power digital signal processing algorithms for an insulated EMG sensor which couples the EMG signal capacitively. These sensors require neither conductive connection to the skin nor electrolytic paste or skin preparation. Capacitive sensors allow straightforward application. However, they make a sophisticated signal amplification and noise suppression necessary. A low-cost sensor has been developed for real-time myoelectric prostheses control. The major hurdles in measuring the EMG are movement artifacts and external noise. We designed various digital filters to attenuate this noise. Optimal system setup and filter parameters for the trade-off between attenuation of this noise and sufficient EMG signal power for high signal quality were investigated. Additionally, an algorithm for movement artifact suppression, enabling robust application in real-world environments, is presented. The algorithms, which require minimal calculation resources and memory, are implemented on an ultra-low-power microcontroller.

Cardiorespiratory and Muscle Metabolic Responses During Conventional Versus Motion Sensor-Assisted Strategies for Functional Electrical Stimulation Standing After Spinal Cord Injury.

This is a case series study with the objective of comparing two motion sensor automated strategies to avert knee buckle during functional electrical stimulation (FES)-standing against a conventional hand-controlled (HC) FES approach. The research was conducted in a clinical exercise laboratory gymnasium at the University of Sydney, Australia. The automated strategies, Aut-A and Aut-B, applied fixed and variable changes of neurostimulation, respectively, in quadriceps amplitude to precisely control knee extension during standing. HC was an "on-demand" increase of stimulation amplitude to maintain stance. Finally, maximal FES amplitude (MA) was used as a control condition, whereby knee buckle was prevented by maximal isometric muscle recruitment. Four AIS-A paraplegics undertook 4 days of testing each, and each assessment day comprised three FES standing trials using the same strategy. Cardiorespiratory responses were recorded, and quadriceps muscle oxygenation was quantified using near-infrared spectroscopy. For all subjects, the longest standing times were observed during Aut-A, followed by Aut-B, and then HC and MA. The standing times of the automated strategies were superior to HC by 9-64%. Apart from a lower heart rates during standing (P = 0.034), the automation of knee extension did not promote different cardiorespiratory responses compared with HC. The standing times during MA were significantly shorter than during the automated or "on-demand" strategies (by 80-250%). In fact, the higher isometric-evoked quadriceps contraction during MA resulted in a greater oxygen demand (P < 0.0001) and wider arteriovenous oxygen extraction (P = 0.08) when compared with the other strategies. In conclusion, even though increased standing times were demonstrated using automated control of knee extension, physiological benefits compared with HC were not evident.

Nonlinear Mapping From EMG to Prosthesis Closing Velocity Improves Force Control With EMG Biofeedback.

When using EMG biofeedback to control the grasping force of a myoelectric prosthesis, subjects need to activate their muscles and maintain the myoelectric signal within an appropriate interval. However, their performance decreases for higher forces, because the myoelectric signal is more variable for stronger contractions. Therefore, the present study proposes to implement EMG biofeedback using nonlinear mapping, in which EMG intervals of increasing size are mapped to equal-sized intervals of the prosthesis velocity. To validate this approach, 20 non-disabled subjects performed force-matching tasks using Michelangelo prosthesis with and without EMG biofeedback with linear and nonlinear mapping. Additionally, four transradial amputees performed a functional task in the same feedback and mapping conditions. The success rate in producing desired force was significantly higher with feedback (65.4±15.9%) compared to no feedback (46.2±14.9%) as well as when using nonlinear (62.4±16.8%) versus linear mapping (49.2±17.2%). Overall, in non-disabled subjects, the highest success rate was obtained when EMG biofeedback was combined with nonlinear mapping (72%), and the opposite for linear mapping with no feedback (39.6%). The same trend was registered also in four amputee subjects. Therefore, EMG biofeedback improved prosthesis force control, especially when combined with nonlinear mapping, which showed to be an effective approach to counteract increasing variability of myoelectric signal for stronger contractions.

A Novel Sensory Feedback Approach to Facilitate Both Predictive and Corrective Control of Grasping Force in Myoelectric Prostheses.

Reliable force control is especially important when using myoelectric upper-limb prostheses as the force defines whether an object will be firmly grasped, damaged, or dropped. It is known from human motor control that the grasping of non-disabled subjects is based on a combination of anticipation and feedback correction. Inspired by this insight, the present study proposes a novel approach to provide artificial sensory feedback to the user of a myoelectric prosthesis using vibrotactile stimulation to facilitate both predictive and corrective processes characteristic of grasping in non-disabled people. Specifically, the level of EMG was conveyed to the subjects while closing the prosthesis (predictive strategy), whereas the actual grasping force was transmitted when the prosthesis closed (corrective strategy). To investigate if this combined EMG and force feedback is indeed an effective method to explicitly close the control loop, 16 non-disabled and 3 transradial amputee subjects performed a set of functional tasks, inspired by the "Box and Block" test, with six target force levels, in three conditions: no feedback, only EMG feedback, and combined feedback. The highest overall performance in non-disabled subjects was obtained with combined feedback (79.6±9.9%), whereas the lowest was achieved with no feedback (53±11.5%). The combined feedback, however, increased the task completion time compared to the other two conditions. A similar trend was obtained also in three amputee subjects. The results, therefore, indicate that the feedback inspired by human motor control is indeed an effective approach to improve prosthesis grasping in realistic conditions when other sources of feedback (vision and audition) are not blocked.

Practical and effective stomal sphincter creation: evaluation in pigs.

PURPOSE: Stoma creation frequently presents complications for which there is no satisfactory surgical solution. We reexamined the feasibility of managing stoma continence with an artificial sphincter, addressing the outstanding issues of geometry, electrode disposition, and fatigue resistance. METHODS: In 6 pigs, 1 rectus abdominis muscle was preconditioned with electric stimulation for 4 weeks by an implanted stimulator. A sphincter was then constructed and tested for its ability to provide continence against saline at a typical intestinal pressure. The result was compared with a sphincter fashioned from the unconditioned contralateral (control) muscle. In each case, stimulation was applied alternately to longitudinal segments. RESULTS: A 2-layered wrap was required to achieve continence. Sphincters created from the preconditioned muscles could sustain continence continuously for at least 90 minutes. CONCLUSION: This study establishes a practical approach to the creation of a sphincter from the rectus abdominis muscle in stoma patients. Continence can be achieved only with a double-layered wrap. Fatigue during long-term operation can be avoided by a combination of preconditioning and segmental stimulation of intramuscular nerve branches.

Capacitively coupled EMG detection via ultra-low-power microcontroller STFT.

As motion artefacts are a major problem with electromyography sensors, a new algorithm is developed to differentiate artefacts to contraction EMG. The performance of myoelectric prosthesis is increased with this algorithm. The implementation is done for an ultra-low-power microcontroller with limited calculation resources and memory. Short Time Fourier Transformation is used to enable real-time application. The sum of the differences (SOD) of the currently measured EMG to a reference contraction EMG is calculated. The SOD is a new parameter introduced for EMG classification. The satisfactory error rates are determined by measurements done with the capacitively coupling EMG prototype, recently developed by the research group.

A novel motion sensor-driven control system for FES-assisted walking after spinal cord injury: A pilot study.

This pilot study reports the development of a novel closed-loop (CL) FES-gait control system, which employed a finite-state controller that processed kinematic feedback from four miniaturized motion sensors. This strategy automated the control of knee extension via quadriceps and gluteus stimulation during the stance phase of gait on the supporting leg, and managed the stimulation delivered to the common peroneal nerve (CPN) during swing-phase on the contra-lateral limb. The control system was assessed against a traditional open-loop (OL) system on two sensorimotor 'complete' paraplegic subjects. A biomechanical analysis revealed that the closed-loop control of leg swing was efficient, but without major advantages compared to OL. CL automated the control of knee extension during the stance phase of gait and for this reason was the method of preference by the subjects. For the first time, a feedback control system with a simplified configuration of four miniaturized sensors allowed the addition of instruments to collect the data of multiple physiological and biomechanical variables during FES-evoked gait. In this pilot study of two sensorimotor complete paraplegic individuals, CL ameliorated certain drawbacks of current OL systems - it required less user intervention and accounted for the inter-subject differences in their stimulation requirements.

Therapeutic stimulation of denervated muscles: the influence of pattern.

Muscular atrophy due to denervation can be substantially reversed by direct electrical stimulation. Some muscle properties are, however, resistant to change. Using a rabbit model of established denervation atrophy, we investigated whether the extent of restoration would vary with the stimulation protocol. Five patterns, delivering 24,000-480,000 impulses/day, were applied for 6 or 10 weeks. The wet weight, cross-sectional area, tetanic tension, shortening velocity, and power of denervated muscles subjected to stimulation all increased significantly. The fibers were larger and more closely packed and there was no evidence of necrosis. There was a small increase in excitability. Isometric twitch kinetics remained slow and fatigue resistance did not improve. The actual pattern of stimulation had no influence on any of these findings. The results, interpreted in the context of ultrastructural changes and an ongoing clinical study, reaffirm the clinical value of introducing stimulation during the initial non-degenerative phase. They indicate that there would be little therapeutic benefit in adopting regimes more energetically demanding than those in current use, and that the focus should now shift to protocols that represent the least intrusion into activities of daily living.

Functional electrical stimulation of denervated muscles: basic issues.

Denervating injuries result in flaccid paralysis and severe atrophy of the affected muscles. This work reviews the potential for functional restoration of such muscles by electrical stimulation, focusing on the basic scientific issues.