SPARC Human Open Research Neural Engineering Technologies (HORNET) Initiative (U41 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
The NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program seeks to accelerate development of therapeutic approaches that modulate electrical activity in peripheral nerves to improve organ function. SPARC is generating maps, tools, and models to identify and influence therapeutic targets that exist within the neural circuitry of a wide range of visceral organs and tissues.
Advancement of such therapeutic approaches from early-stage development to successful clinical translation requires the availability of clinical-grade neuromodulation platforms. Currently, such platforms are either costly to develop from the ground up or difficult to access for exploratory use from large medical device companies (SPARC Stage Two Strategic Planning Summary). These barriers to translation have hindered the research community from bringing innovative therapeutic approaches to the patients who need them most. Creating an open-source technology ecosystem will help to eliminate these hurdles and accelerate the translation of new therapies into the clinic. Motivated by the observation that most neuromodulation approaches utilize the same technology elements (e.g., hardware, signal processing algorithms, software, and firmware), SPARC seeks to develop neuromodulation systems that can be applied across biomedical applications. The development of interoperable modules and full neuromodulation systems should ultimately lower regulatory hurdles to better facilitate translation of new therapies to humans.
The primary goal of the SPARC Human Open-Research Neural Engineering Technologies (HORNET) initiative is to advance the clinical translation of neuromodulation therapies in humans by supporting the development of this open-source ecosystem. Awardees of the HORNET program will develop open-source neuromodulation libraries that include multiple “templates” that describe combinations of individual technology modules necessary to construct complete, fully functional neuromodulation systems. Modules may include any hardware, firmware, and software elements that are combined to define a neuromodulation system. The neuromodulation systems should be applicable to a variety of peripheral nervous system applications, with potential applicability in the central nervous system as well. The open-source neuromodulation libraries should include engineering designs, regulatory documentation, technical specifications, manufacturing and assembly processes, testing and validation reports, firmware designs, software code, etc. Examples of hardware include, but are not limited to, electrodes, leads, connectors, electronics, telemetry components, batteries, enclosures, hermetic technologies, and insulation layers. Firmware may include digital informatics, machine learning, analytical algorithms, cloud computing, wireless communication, etc. Software-design considerations may include supporting different use cases, setting optimal stimulation parameters, enabling closed-loop control techniques, ways to adapt to multiple types of biomedical applications, and integration of a device into clinical workflows. Designed technology modules should be integrated into a functional neuromodulation system suitable for a specific translational research need. By requiring that these systems are designed for compliance with the regulatory expectations of the FDA, the regulatory burden of translating a technology will be significantly eased.
Application budgets are not limited, but need to reflect the actual needs of the proposed project.
January 12, 2022
Eric Hudak, Ph. D; Brooks Gross, Ph.D.; National Institute of Neurological Disorders and Stroke (NINDS); Telephone: 301-496-1779; Email: SPARC-O@od.nih.gov