Request for Information (RFI): Neuromodulation Technology Needs and Challenges to Enable SPARC (Stimulating Peripheral Activity to Relieve Conditions)
Notice Number:
NOT-RM-14-017
Key Dates
Release Date: October 28, 2014
Response Date: November 25, 2014
Related Announcements
Issued by
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
Purpose
The National Institutes of Health (NIH) seeks input on a new program, Stimulating Peripheral Activity to Relieve Conditions (http://commonfund.nih.gov/sparc/index), to deliver detailed, integrated functional and anatomical neural circuit maps in multiple organ systems. These maps will be directly leveraged to develop and pilot multiple novel electrode designs, with corresponding stimulation protocols and minimally invasive surgical procedures, to improve existing neuromodulation therapies or pursue new indications. SPARC will provide the scientific foundation required to catalyze the development of new and/or more efficacious therapies utilizing closed-loop neuromodulation to modulate end-organ system function. This will be accomplished primarily by generating detailed functional maps of end-organ systems in appropriate animal models, while validating the relevance of these maps for human translation. The NIH is interested in understanding how cellular and tissue based responses form the underlying mechanisms of neural control networks. SPARC is primarily focused on autonomic nervous system control of, and sensory feedback from, internal organs, but interests may extend beyond these to other organs that show promise for development of neuromodulation therapies.
Pending the availability of funds, SPARC will be implemented starting in FY2015 by the NIH Common Fund which supports cross-cutting programs that are expected to have exceptionally high impact. The SPARC program is a high-risk, goal-driven endeavor to provide insights into the neural control of organ function, and lay the foundation for development of neural control devices to precisely treat a wide variety of diseases and conditions.
The NIH seeks input from the biomedical research community, potential biotechnology and pharmaceutical company partners, and other members of the public on this new program. Through the SPARC program, the NIH plans to support interdisciplinary teams of investigators to deliver neural circuit maps of several organ systems, novel electrode designs, minimally invasive surgical procedures, and stimulation protocols. Driven by end goals of improving existing and developing new neuromodulation therapies, the program will be iterative and dynamic, with the novel technologies informing mapping efforts, and the mapping results defining new technology requirements.
Current plans for SPARC include potential initiatives to:
- Deliver detailed, integrated functional/anatomical neural circuit maps in multiple organs or organ systems for understanding the underlying mechanisms of control; develop/pilot novel electrode designs, surgical procedures, and stimulation protocols leveraging insights from the functional maps (see NOT-RM-14-016 for details)
- Develop next-generation technology for stimulating and recording of visceral nerves and tissues, e.g., optogenetics, stimulating/recording electrodes, cell-type specific tracing (subject of this current RFI)
- Partner with industry and FDA to explore utility of existing, approved devices to address new, small-market indications (see NOT-RM-14-015 for details)
- Assemble data from all SPARC initiatives into a coordinated data resource, develop user-friendly computational tools, and incorporate new computer modeling methods
This RFI is intended to gather information and identify interested parties to inform a follow-on workshop. The RFI and workshop may lead to a subsequent funding opportunity announcement; however, this RFI should not be construed as a funding opportunity. Additional information, including future funding announcements for SPARC can be found at: http://commonfund.nih.gov/sparc/index).
Information Requested
This RFI is focused on the planned initiative, "Technology Development for Next Generation Peripheral Activation of Organ Function". It invites input from the scientific community, potential industry partners, and other members of the public on all aspects of the program. Small businesses with appropriate technologies are especially encouraged to provide input. Please provide perspectives and pertinent references, as well as names of key experts related to any of the following topics, though your comments are not limited to these topics:
- SPARC is interested in technology solutions to map, record, stimulate, and understand the underlying mechanisms controlling the internal organs. The community is invited to comment on the level of knowledge and research currently performed on these organs and organ systems in the context of technologies for neuromodulation, understanding cellular and tissue mechanisms of action, and disease/symptom control.
- The most important problem that can be addressed by neuromodulation of internal organs, which can lead to tangible clinical benefit. Identifiable short-term to long-term goals and low risk to high risk targets
- Unique technology challenges associated with SPARC data collection, curation, integration and analysis
- Challenges associated with the sharing of neuroanatomy data and neuromodulation tools across the research and technology groups, as well as with the public
- Use/modification of existing neural prosthesis and neuromodulation technology (e.g., cochlear implant, retinal prosthesis, Deep Brain Stimulation) for other end-organ systems, as well as lessons learned for training and new technology development
- Activity sensors and associated imaging technologies suitable for peripheral nerve and end-organ monitoring (e.g., voltage probes)
- Technologies for cell-class specific targeting and manipulation in peripheral nerves and ganglia, appropriate for multiple animal models with clinical relevance (e.g., optogenetics)
- Reliable high density recording/stimulating electrodes with manufacturing process scalable to a wide range of nerve sizes and locations, appropriate for use in animal models
- Less invasive technologies for tunable stimulation/inhibition/block of nerve activity (e.g., ultrasound, magnetic fields, etc.)
- Sensing techniques for relevant biomarkers to inform closed-loop response systems (e.g., biomolecule sampling/measuring)
- Tools for non-invasive tracing, functional imaging, and microendoscopic surgical techniques necessary to facilitate minimally invasive surgeries in humans, including technology to explore human neuroanatomy post-mortem
- Advanced computational methods to model functional neuroanatomy as it pertains to end-organ systems, and to model and predict effects and side-effects of electrical stimulation based on functional anatomy and mechanisms of action to stratify responders and non-responders
- Next-generation technology to validate and optimize computational models by directly observing electrical activity induced at the neural-interface while simultaneously measuring changes in activity at all points in the organ system
- Computational models that address multi-scale data integration of neuronal, chemical, metabolic, and other end organ activity markers
How to Submit a Response
To ensure consideration, responses must be received by November 25, 2014, and must be submitted to [email protected]. NIH will provide automatic confirmation of response submission, but respondents will not receive individualized feedback.
Responses to this RFI are voluntary and may be submitted either anonymously or with identifying information. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments may be compiled for discussion and may appear in related reports. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled.
This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government to provide support for any ideas submitted in response to it. Please note that the US Government will not pay for the preparation of any information submitted, or for its use of that information.
Reference:
1. Birmingham, K., et al., Bioelectronics Medicine: a research roadmap. Nature 13: 399-400, 2014.
Inquiries
Please direct all inquiries to:
Grace C. Y. Peng, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: [email protected]
and Human Services (HHS)
