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Bioelectronic therapies modulating the vagus nerve are promising for cardiovascular, inflammatory, and mental disorders. Clinical applications are however limited by side-effects such as breathing obstruction and headache caused by non-specific stimulation. To design selective and functional stimulation, we engineered VaStim, a realistic and efficient in-silico model. We developed a protocol to personalize VaStim in-vivo using simple muscle responses, successfully reproducing experimental observations, by combining models with trials conducted on five pigs. Through optimized algorithms, VaStim simulated the complete fiber population in minutes, including often omitted unmyelinated fibers which constitute 80% of the nerve. The model suggested that all Aα-fibers across the nerve affect laryngeal muscle, while heart rate changes were caused by B-efferents in specific fascicles. It predicted that tripolar paradigms could reduce laryngeal activity by 70% compared to typically used protocols. VaStim may serve as a model for developing neuromodulation therapies by maximizing efficacy and specificity, reducing animal experimentation.
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Simulación por Computador , Estimulación del Nervio Vago , Nervio Vago , Animales , Porcinos , Nervio Vago/fisiología , Estimulación del Nervio Vago/métodos , Frecuencia Cardíaca/fisiología , AlgoritmosRESUMEN
Facial paralysis is the inability to move facial muscles thereby impairing the ability to blink and make facial expressions. Depending on the localization of the nerve malfunction it is subcategorised into central or peripheral and is usually unilateral. This leads to health deficits stemming from corneal dryness and social ostracization.Objective: Electrical stimulation shows promise as a method through which to restore the blink function and as a result improve eye health. However, it is unknown whether a real-time, myoelectrically controlled, neurostimulating device can be used as assistance to this pathological condition.Approach: We developed NEURO-BLINK, a wearable robotic system, that can detect the volitional healthy contralateral blink through electromyography and electrically stimulate the impaired subcutaneous facial nerve and orbicularis oculi muscle to compensate for lost blink function. Alongside the system, we developed a method to evaluate optimal electrode placement through the relationship between blink amplitude and injected charge.Main results: Ten patients with unilateral facial palsy were enrolled in the NEURO-BLINK study, with eight completing testing under two conditions. (1) where the stimulation was cued with an auditory signal (i.e. paced controlled) and (2) synchronized with the natural blink (i.e. myoelectrically controlled). In both scenarios, overall eye closure (distance between eyelids) and cornea coverage measured with high FPS video were found to significantly improve when measured in real-time, while no significant clinical changes were found immediately after use.Significance: This work takes steps towards the development of a portable medical device for blink restoration and facial stimulation which has the potential to improve long-term ocular health.
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Parálisis Facial , Humanos , Biónica , Parpadeo , Párpados/inervación , Nervio FacialRESUMEN
Peripheral nerve stimulation is being investigated as a therapeutic tool in several clinical scenarios. However, the adopted devices have restricted ability to obtain desired outcomes with tolerable off-target effects. Recent promising solutions are not yet employed in clinical practice due to complex required surgeries, lack of long-term stability, and implant invasiveness. Here, we aimed to design a neural interface to address these issues, specifically dimensioned for pudendal and sacral nerves to potentially target sexual, bladder, or bowel dysfunctions. We designed the adaptable intrafascicular radial electrode (AIR) through realistic computational models. They account for detailed human anatomy, inhomogeneous anisotropic conductance, following the trajectories of axons along curving and branching fascicles, and detailed biophysics of axons. The model was validated against available experimental data. Thanks to computationally efficient geometry-based selectivity estimations we informed the electrode design, optimizing its dimensions to obtain the highest selectivity while maintaining low invasiveness. We then compared the AIR with state-of-the-art electrodes, namely InterStim leads, multipolar cuffs and transversal intrafascicular multichannel electrodes (TIME). AIR, comprising a flexible substrate, surface active sites, and radially inserted intrafascicular needles, is designed to be implanted in a few standard steps, potentially enabling fast implants. It holds potential for repeatable stimulation outcomes thanks to its radial structural symmetry. When compared in-silico, AIR consistently outperformed cuff electrodes and InterStim leads in terms of recruitment threshold and stimulation selectivity. AIR performed similarly or better than a TIME, with quantified less invasiveness. Finally, we showed how AIR can adapt to different nerve sizes and varying shapes while maintaining high selectivity. The AIR electrode shows the potential to fill a clinical need for an effective peripheral nerve interface. Its high predicted performance in all the identified requirements was enabled by a model-based approach, readily applicable for the optimization of electrode parameters in any peripheral nerve stimulation scenario.
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Axones , Nervios Periféricos , Humanos , Diseño de Equipo , Estimulación Eléctrica/métodos , Electrodos , Nervios Periféricos/fisiología , Axones/fisiología , Electrodos ImplantadosRESUMEN
Peripheral nerve stimulation in amputees achieved the restoration of touch, but not proprioception, which is critical in locomotion. A plausible reason is the lack of means to artificially replicate the complex activity of proprioceptors. To uncover this, we coupled neuromuscular models from ten subjects and nerve histologies from two implanted amputees to develop ProprioStim: a framework to encode proprioception by electrical evoking neural activity in close agreement with natural proprioceptive activity. We demonstrated its feasibility through non-invasive stimulation on seven healthy subjects comparing it with standard linear charge encoding. Results showed that ProprioStim multichannel stimulation was felt more natural, and hold promises for increasing accuracy in knee angle tracking, especially in future implantable solutions. Additionally, we quantified the importance of realistic 3D-nerve models against extruded models previously adopted for further design and validation of novel neurostimulation encoding strategies. ProprioStim provides clear guidelines for the development of neurostimulation policies restoring natural proprioception.
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BACKGROUND: The inability of users to directly and intuitively control their state-of-the-art commercial prosthesis contributes to a low device acceptance rate. Since Electromyography (EMG)-based control has the potential to address those inabilities, research has flourished on investigating its incorporation in microprocessor-controlled lower limb prostheses (MLLPs). However, despite the proposed benefits of doing so, there is no clear explanation regarding the absence of a commercial product, in contrast to their upper limb counterparts. OBJECTIVE AND METHODOLOGIES: This manuscript aims to provide a comparative overview of EMG-driven control methods for MLLPs, to identify their prospects and limitations, and to formulate suggestions on future research and development. This is done by systematically reviewing academical studies on EMG MLLPs. In particular, this review is structured by considering four major topics: (1) type of neuro-control, which discusses methods that allow the nervous system to control prosthetic devices through the muscles; (2) type of EMG-driven controllers, which defines the different classes of EMG controllers proposed in the literature; (3) type of neural input and processing, which describes how EMG-driven controllers are implemented; (4) type of performance assessment, which reports the performance of the current state of the art controllers. RESULTS AND CONCLUSIONS: The obtained results show that the lack of quantitative and standardized measures hinders the possibility to analytically compare the performances of different EMG-driven controllers. In relation to this issue, the real efficacy of EMG-driven controllers for MLLPs have yet to be validated. Nevertheless, in anticipation of the development of a standardized approach for validating EMG MLLPs, the literature suggests that combining multiple neuro-controller types has the potential to develop a more seamless and reliable EMG-driven control. This solution has the promise to retain the high performance of the currently employed non-EMG-driven controllers for rhythmic activities such as walking, whilst improving the performance of volitional activities such as task switching or non-repetitive movements. Although EMG-driven controllers suffer from many drawbacks, such as high sensitivity to noise, recent progress in invasive neural interfaces for prosthetic control (bionics) will allow to build a more reliable connection between the user and the MLLPs. Therefore, advancements in powered MLLPs with integrated EMG-driven control have the potential to strongly reduce the effects of psychosomatic conditions and musculoskeletal degenerative pathologies that are currently affecting lower limb amputees.
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Amputados , Miembros Artificiales , Electromiografía/métodos , Humanos , CaminataRESUMEN
Above-knee amputees suffer the lack of sensory information, even while using most advanced prostheses. Restoring intraneural sensory feedback results in functional and cognitive benefits. It is unknown how this artificial feedback, restored through a neuro-robotic leg, influences users' sensorimotor strategies and its implications for future wearable robotics. To unveil these mechanisms, we measured gait markers of a sensorized neuroprosthesis in two leg amputees during motor tasks of different difficulty. Novel sensorimotor strategies were intuitively promoted, allowing for a higher walking speed in both tasks. We objectively quantified the augmented prosthesis' confidence and observed the reshaping of the legs' kinematics toward a more physiological gait. In a possible scenario of a leg amputee driving a conventional car, we showed a finer pressure estimation from the prosthesis. Users exploited different features of the neural stimulation during tasks, suggesting that a simple prosthesis sensorization could be effective for future neuro-robotic prostheses.
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Neurointerfaces have acquired major relevance as both rehabilitative and therapeutic tools for patients with spinal cord injury, limb amputations and other neural disorders. Bidirectional neural interfaces are a key component for the functional control of neuroprosthetic devices. The two main neuroprosthetic applications of interfaces with the peripheral nervous system (PNS) are: the refined control of artificial prostheses with sensory neural feedback, and functional electrical stimulation (FES) systems attempting to generate motor or visceral responses in paralyzed organs. The results obtained in experimental and clinical studies with both, extraneural and intraneural electrodes are very promising in terms of the achieved functionality for the neural stimulation mode. However, the results of neural recordings with peripheral nerve interfaces are more limited. In this paper we review the different existing approaches for PNS signals recording, denoising, processing and classification, enabling their use for bidirectional interfaces. PNS recordings can provide three types of signals: i) population activity signals recorded by using extraneural electrodes placed on the outer surface of the nerve, which carry information about cumulative nerve activity; ii) spike activity signals recorded with intraneural electrodes placed inside the nerve, which carry information about the electrical activity of a set of individual nerve fibers; and iii) hybrid signals, which contain both spiking and cumulative signals. Finally, we also point out some of the main limitations, which are hampering clinical translation of neural decoding, and indicate possible solutions for improvement.