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.

Increased alertness, better than posture prioritization, explains dual-task performance in prosthesis users and controls under increasing postural and cognitive challenge.

Sensorimotor impairments after limb amputation impose a threat to stability. Commonly described strategies for maintaining stability are the posture first strategy (prioritization of balance) and posture second strategy (prioritization of concurrent tasks). The existence of these strategies was examined in 13 below-knee prosthesis users and 15 controls during dual-task standing under increasing postural and cognitive challenge by evaluating path length, 95% sway area, and anterior-posterior and medial-lateral amplitudes of the center of pressure. The subjects stood on two force platforms under usual (hard surface/eyes open) and difficult (soft surface/eyes closed) conditions, first alone and while performing a cognitive task without and then with instruction on cognitive prioritization. During standing alone, sway was not significantly different between groups. After adding the cognitive task without prioritization instruction, prosthesis users increased sway more under the dual-task than single-task standing (p ≤ 0.028) during both usual and difficult conditions, favoring the posture second strategy. Controls, however, reduced dual-task sway under a greater postural challenge (p ≤ 0.017), suggesting the posture first strategy. With prioritization of the cognitive task, sway was unchanged or reduced in prosthesis users, suggesting departure from the posture second strategy, whereas controls maintained the posture first strategy. Individual analysis of dual tasking revealed that greater postural demand in controls and greater cognitive challenge in prosthesis users led to both reduced sway and improved cognitive performance, suggesting cognitive-motor facilitation. Thus, activation of additional resources through increased alertness, rather than posture prioritization, may explain dual-task performance in both prosthesis users and controls under increasing postural and cognitive challenge.

The utility of the single-subject method for comparison of temporal-spatial gait changes between a microprocessor and non-microprocessor prosthetic knees.

BACKGROUND: Despite increasing knowledge about the potential benefits of advanced user-controlled technology, the decision about switching an individual prosthesis user from a non-microprocessor prosthetic knee to a microprocessor prosthetic knee is mainly based on clinician's experience rather than empirical evidence. OBJECTIVES: To demonstrate the utility of single-subject design and data analysis for evaluating changes in temporal-spatial gait characteristics between walking with a non-microprocessor prosthetic knee and microprocessor prosthetic knee. STUDY DESIGN: Single-subject ABA/BAB design. METHODS: Seven non-microprocessor prosthetic knee users (all men, age 50-84 years, 3-40 years post-amputation) were transitioned through the ABA or BAB phases (A-NMPK, B-MPK, 5 weeks each). Four weekly gait evaluations were performed at three self-selected speeds with an electronic walkway. The non-microprocessor prosthetic knee-microprocessor prosthetic knee differences in stride length-cadence relationship, prosthetic weight acceptance, single-limb support, and step width were evaluated for each subject using the "non-overlap of all pairs" statistical method. RESULTS: Most subjects improved temporal-spatial gait while on the microprocessor prosthetic knee; in only one subject, none of the 10 gait parameters were in favor of the microprocessor prosthetic knee. In the BAB group, longer use of the microprocessor prosthetic knee was associated with shorter prosthetic weight acceptance and longer single-limb support times across three speeds. Step width either improved with the microprocessor prosthetic knee or remained unchanged in most subjects. CONCLUSION: The evidence of individual subject improvements in gait coordination, greater reliance on the prosthetic side, and better stability with the microprocessor prosthetic knee than non-microprocessor prosthetic knee over a range of walking speeds demonstrate the practical utility of the single-subject method in clinical decision-making. CLINICAL RELEVANCE: The results demonstrate the use of the single-subject method for examining person-specific differences in temporal-spatial gait characteristics between walking with a non-microprocessor prosthetic knee and microprocessor prosthetic knee at three self-selected speeds. The method proved feasible and reliable for documenting changes in gait at the individual level, which is relevant for clinical practice.

Comparison of mobility and user satisfaction between a microprocessor knee and a standard prosthetic knee: a summary of seven single-subject trials.

Insufficient evidence of the benefits provided by costlier microprocessor knees (MPKs) over nonmicroprocessor knees (NMPKs) often causes concern when considering MPK prescription. Thus, more studies are needed to demonstrate differences between MPKs and NMPKs and define sensitive outcomes to guide MPK prescription. The aim of this study was to evaluate the impact of switching from NMPK to MPK on measures of mobility and preference. Seven long-term NMPK users (all men, ages 50-84, 3-64 years postamputation) participated in this study, which use a single-subject design (ABA or BAB; A=NMPK, B=MPK). Mobility was assessed with the Amputee Mobility Predictor, Berg Balance Scale (BBS), L-Test, 6-Min Walk Test (6MWT) with Physiological Cost Index, and self-selected normal and very fast gait speeds. The preference between NMPK and MPK was evaluated by the Prosthesis Evaluation Questionnaire (PEQ) and the visual analog scale. Mobility improved with the MPK in six of seven participants, which was most often captured with BBS (median: +6 points) and 6MWT (median: +63 m). These improvements typically exceeded minimal clinically important difference or minimal detectable change thresholds. Most participants scored the MPK higher on the PEQ (median: +20 points) and six of seven expressed a global preference toward MPK. In the BAB group, the Amputee Mobility Predictor and BBS correlated with perception of change on several PEQ domains (Ρ≥0.59). In conclusion, MPKs may provide better outcomes and user satisfaction, particularly in those with lower mobility function. BBS and 6MWT were found to be the most sensitive measures to capture changes in mobility while using MPK for several weeks.

Residual standard deviation: Validation of a new measure of dual-task cost in below-knee prosthesis users.

We developed and evaluated properties of a new measure of variability in stride length and cadence, termed residual standard deviation (RSD). To calculate RSD, stride length and cadence are regressed against velocity to derive the best fit line from which the variability (SD) of the distance between the actual and predicted data points is calculated. We examined construct, concurrent, and discriminative validity of RSD using dual-task paradigm in 14 below-knee prosthesis users and 13 age- and education-matched controls. Subjects walked first over an electronic walkway while performing separately a serial subtraction and backwards spelling task, and then at self-selected slow, normal, and fast speeds used to derive the best fit line for stride length and cadence against velocity. Construct validity was demonstrated by significantly greater increase in RSD during dual-task gait in prosthesis users than controls (group-by-condition interaction, stride length p=0.0006, cadence p=0.009). Concurrent validity was established against coefficient of variation (CV) by moderate-to-high correlations (r=0.50-0.87) between dual-task cost RSD and dual-task cost CV for both stride length and cadence in prosthesis users and controls. Discriminative validity was documented by the ability of dual-task cost calculated from RSD to effectively differentiate prosthesis users from controls (area under the receiver operating characteristic curve, stride length 0.863, p=0.001, cadence 0.808, p=0.007), which was better than the ability of dual-task cost CV (0.692, 0.648, respectively, not significant). These results validate RSD as a new measure of variability in below-knee prosthesis users. Future studies should include larger cohorts and other populations to ascertain its generalizability.