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Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.

ABSTRACT: Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the "Networked Neuroprosthesis" (NNP), was developed. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. This paper describes the design of stimulation and recording modules, bench testing to verify stimulus outputs and appropriate filtering and recording, and validation that the components function properly while implemented in persons with spinal cord injury. The results of system testing demonstrated that the NNP was functional and capable of generating stimulus pulses and recording myoelectric, temperature, and accelerometer signals. Based on the successful design, manufacturing, and testing of the NNP System, multiple clinical applications are anticipated.

SUBMITTER: Makowski N

PROVIDER: S-EPMC8344369 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.

Makowski Nathaniel N Campean Alexandru A Lambrecht Joris J Buckett James J Coburn James J Hart Ronald R Miller Michael M Montague Fred F Crish Timothy T Fu Michael M Kilgore Kevin K Peckham P Hunter PH Smith Brian B

IEEE transactions on biomedical circuits and systems 20210401 2

Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the "Networked Neuroprosthesis" (NNP), was developed. The NNP system is the first fully im ...[more]

PMID: 33729949

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Project description:BackgroundDespite important advancements in control and mechatronics of myoelectric prostheses, the communication between the user and his/her bionic limb is still unidirectional, as these systems do not provide somatosensory feedback. Electrotactile stimulation is an attractive technology to close the control loop since it allows flexible modulation of multiple parameters and compact interface design via multi-pad electrodes. However, the stimulation interferes with the recording of myoelectric signals and this can be detrimental to control.MethodsWe present a novel compact solution for simultaneous recording and stimulation through dynamic blanking of stimulation artefacts. To test the system, a feedback coding scheme communicating wrist rotation and hand aperture was developed specifically to stress the myoelectric control while still providing meaningful information to the subjects. Ten subjects participated in an experiment, where the quality of closed-loop myoelectric control was assessed by controlling a cursor in a two degrees of freedom target-reaching task. The benchmark performance with visual feedback was compared to that achieved by combining visual feedback and electrotactile stimulation as well as by using electrotactile feedback only.ResultsThere was no significant difference in performance between visual and combined feedback condition with regards to successfully reached targets, time to reach a target, path efficiency and the number of overshoots. Therefore, the quality of myoelectric control was preserved in spite of the stimulation. As expected, the tactile condition was significantly poorer in completion rate (100/4% and 78/25% for combined and tactile condition, respectively) and time to reach a target (9/2 s and 13/4 s for combined and tactile condition, respectively). However, the performance in the tactile condition was still good, with no significant difference in path efficiency (38/8%) and the number of overshoots (0.5/0.4 overshoots), indicating that the stimulation was meaningful for the subjects and useful for closed-loop control.ConclusionsOverall, the results demonstrated that the developed system can provide robust closed-loop control using electrotactile stimulation. The system supports different encoding schemes and allows placing the recording and stimulation electrodes next to each other. This is an important step towards an integrated solution where the developed unit will be embedded into a prosthetic socket.

Project description:MotivationThe clinical success of brain-machine interfaces depends on overcoming both biological and material challenges to ensure a long-term stable connection for neural recording and stimulation. Therefore, there is a need to quantify any damage that microelectrodes sustain when they are chronically implanted in the human cortex.MethodsUsing scanning electron microscopy (SEM), we imaged 980 microelectrodes from Neuroport arrays chronically implanted in the cortex of three people with tetraplegia for 956-2246 days. We analyzed eleven multi-electrode arrays in total: eight arrays with platinum (Pt) electrode tips and three with sputtered iridium oxide tips (SIROF); one Pt array was left in sterile packaging, serving as a control. The arrays were implanted/explanted across three different clinical sites surgeries (Caltech/UCLA, Caltech/USC and APL/Johns Hopkins) in the anterior intraparietal area, Brodmann's area 5, motor cortex, and somatosensory cortex.Human experts rated the electron micrographs of electrodes with respect to five damage metrics: the loss of metal at the electrode tip, the amount of separation between the silicon shank and tip metal, tissue adherence or bio-material to the electrode, damage to the shank insulation and silicone shaft. These metrics were compared to functional outcomes (recording quality, noise, impedance and stimulation ability).ResultsDespite higher levels of physical degradation, SIROF electrodes were twice as likely to record neural activity than Pt electrodes (measured by SNR), at the time of explant. Additionally, 1 kHz impedance (measured in vivo prior to explant) significantly correlated with all physical damage metrics, recording, and stimulation performance for SIROF electrodes (but not Pt), suggesting a reliable measurement of in vivo degradation.We observed a new degradation type, primarily occurring on stimulated electrodes ("pockmarked" vs "cracked") electrodes; however, tip metalization damage was not significantly higher due to stimulation or amount of charge. Physical damage was centralized to specific regions of an array often with differences between outer and inner electrodes. This is consistent with degradation due to contact with the biologic milieu, influenced by variations in initial manufactured state. From our data, we hypothesize that erosion of the silicon shank often precedes damage to the tip metal, accelerating damage to the electrode / tissue interface.ConclusionsThese findings link quantitative measurements, such as impedance, to the physical condition of the microelectrodes and their capacity to record and stimulate. These data could lead to improved manufacturing or novel electrode designs to improve long-term performance of BMIs making them are vitally important as multi-year clinical trials of BMIs are becoming more common.

Project description:ObjectivesThis article presents a method-including hardware configuration, sampling rate, filtering settings, and other data analysis techniques-to measure evoked compound action potentials (ECAPs) during spinal cord stimulation (SCS) in humans with externalized percutaneous electrodes. The goal is to provide a robust and standardized protocol for measuring ECAPs on the non-stimulation contacts and to demonstrate how measured signals depend on hardware and processing decisions.MethodsTwo participants were implanted with percutaneous leads for the treatment of chronic pain with externalized leads during a trial period for stimulation and recording. The leads were connected to a Neuralynx ATLAS system allowing us to simultaneously stimulate and record through selected electrodes. We examined different hardware settings, such as online filters and sampling rate, as well as processing techniques, such as stimulation artifact removal and offline filters, and measured the effects on the ECAPs metrics: the first negative peak (N1) time and peak-valley amplitude.ResultsFor accurate measurements of ECAPs, the hardware sampling rate should be least at 8 kHz and should use a high pass filter with a low cutoff frequency, such as 0.1 Hz, to eliminate baseline drift and saturation (railing). Stimulation artifact removal can use a double exponential or a second-order polynomial. The polynomial fit is 6.4 times faster on average in computation time than the double exponential, while the resulting ECAPs' N1 time and peak-valley amplitude are similar between the two. If the baseline raw measurement drifts with stimulation, a median filter with a 100-ms window or a high pass filter with an 80-Hz cutoff frequency preserves the ECAPs.ConclusionsThis work is the first comprehensive analysis of hardware and processing variations on the observed ECAPs from SCS leads. It sets recommendations to properly record and process ECAPs from the non-stimulation contacts on the implantable leads.

Dataset Information

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.

Publications

Design and Testing of Stimulation and Myoelectric Recording Modules in an Implanted Distributed Neuroprosthetic System.

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