Edited by Stavros Zanos, Timir Datta-Chaudhuri, Vasiliki Giagka, Loren Rieth, and Theodoros Zanos
For this thematic series we would like to invite original contributions and reviews in the following areas:
1. Novel neural interfaces
Neural interfaces are at the core of the interaction between the body and bioelectronic medicine. Interfaces that enable electrical or optical tissue activation, as well as the recording of neural or muscular activity, or other types of biosensing or tissue monitoring are paramount to enable testing of new treatment paradigms. The development of such interfaces often encounters challenges or trade-offs in terms of resolution, size, biocompatibility, and stability. Advances in the aforementioned areas are therefore necessary for the development of more sophisticated bioelectronic therapies. One of the critical challenges is exemplified by electrode materials, with the need to enable long-term reliability in stimulation and recording of microscale electrode sites. Encapsulation materials also present a challenge, as smaller targets require thinner materials and smaller electrodes. The integration of these devices, and components such as leads, connectors, and packaging are also critical to long-term safety and efficacy, and are often overlooked in academic research.
2. Methods, systems, and applications of targeted neuromodulation
To realize its full potential, bioelectronic medicine has to develop therapies that address two major limitations of pharmaceuticals: the lack of specificity with regards to organ (i.e. systemic side effects) and the lack of specificity with regards to time (i.e. closed-loop dose-response). Targeting neuromodulation to specific organs, by engaging the nerves and nerve fibers that supply those organs and delivering neurostimulation on an as-needed basis, will maximize effectiveness and minimize unwanted side effects of bioelectronic medicine. Organ specificity will be made possible first through a better understanding of the macro- and microscopic anatomy of the targeted neural circuits and then by developing methods and technologies for targeting specific fiber types. Such methods include fiber-selecting electrical stimulation waveforms, transgenic and viral delivery approaches for cell-specific optogenetic stimulation, and focused ultrasound energy to modulate specific neural circuits in a minimally- or non-invasive manner. The temporal specificity will be accomplished with software and hardware systems, and algorithms for neuromodulation that respond to certain neural signatures or physiological states (“responsive”) and adapt to a constantly-changing physiology as well as to an evolving electrode-tissue interface (“adaptive”).
3. Advances in bioelectronic data analytics
Our bodies have built-in neural reflexes that continuously monitor organ function and maintain physiological homeostasis. While the field of bioelectronic medicine and neuromodulation has mainly focused on the stimulation of neural circuits to treat various conditions, recent studies have explored the possibility of leveraging the sensory arm of these reflexes to diagnose disease states. To accomplish this, neural signals emanating from the body’s built-in biosensors and propagating through peripheral nerves must be recorded and decoded in order to identify the presence or levels of relevant biomarkers of disease. The process of acquiring these signals poses several technical challenges related to the neural interfaces, electronics, recording techniques, and data-processing frameworks. However, these challenges can be addressed with a rigorous experimental approach and new advances in implantable electrodes, signal processing, and machine learning methods. Successfully decoding peripheral nerve activity related to disease states will not only enable the development of real-time diagnostic devices, but also help in advancing closed-loop neuromodulation technologies.
4. New implantable bioelectronic devices
Devices for bioelectronic medicine have to overcome a number of unique challenges beyond the standard development of implantable medical devices. Studying disease is performed in various ways which range from ex vivo methods to a number of different animal models. The selected animal model dictates and often severely constrains the further mass development of new devices. Existing techniques for packaging, power delivery, data telemetry, and on-board signal processing do not readily translate to smaller rodent models. Novel, system-level solutions that address the tradeoff between functionality and size while ensuring long-term operation are necessary to enable the study of new treatment paradigms.
5. Translation of bioelectronic therapies
Bioelectronic therapies need sufficient regulatory data, to support the initiation of clinical trials. This involves development and utilization of preclinical disease models, in addition to extensive safety testing for the devices with respect to biocompatibility, electrical safety, and other areas. Different animal models for subjects of all sizes have different advantages and pose different practical and scientific challenges in the translation process. The development of reliable acute and chronic nerve implants is required for preclinical delivery of these therapies. Understanding of the neuroanatomic and neurophysiologic basis of disease processes and of the neural adaptations that are associated with them will inform the engineering, surgical, and functional aspects of bioelectronic therapies. Selection of the appropriate therapeutic read-outs, and of safety and efficacy criteria in preclinical studies will help guide future clinical trials as well as regulatory and market trajectories.
You can submit to this series, here.