Request for Information (RFI): Research on Neural Control and Neuromodulation of Organ Function to Enable SPARC (Stimulating Peripheral Activity to Relieve Conditions)
Notice Number:
NOT-RM-14-016
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.
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 (subject of this current RFI)
- Develop next-generation technology for stimulating and recording of visceral nerves and tissues, e.g., optogenetics, stimulating/recording electrodes, cell-type specific tracing (see NOT-RM-14-017 for details)
- 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, "Functional and Anatomical Mapping of Multiple Organ Systems." 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:
- Current understanding of neuroanatomy of organs with regard to anatomical variability, functional mapping and molecular identity of neuronal cell types
- Regulation of neuronal signals by non-neuronal cell types in organs
- Signal transmission at the end-organ, including mechanistic understanding of intrinsic neural circuitry
- Autonomic nervous system contributions to organ function
- Sensory feedback from organs and contributions of organ sensory feedback to organ function
- Contributions to specific disease or organ dysfunction by altered autonomic or organ sensory feedback activity
- Neuromodulation approaches to organ diseases and conditions
- Conditions and/or diseases which may benefit from neuromodulation-based therapy, but for which neuromodulation therapy is not yet available
- Gaps in knowledge of relevant organ function or disease that must be overcome to develop neuromodulation-based therapy
- Animal models of human organ autonomic and sensory innervation and diseases
- Methods of neuroanatomical and functional mapping of the autonomic and sensory innervation of organs in humans
- Technologies in use and under development for anatomical mapping of the innervation of organs
- Assays and biomarkers in use and under development to assess end organ function and nervous system modulation of function
- Types of expertise needed for partnerships with technology developers or any other collaborations needed to enable further rapid progress in both research and clinical efforts
- Types of data that would likely be generated from studies of neuroanatomy and neuromodulation of organ function and disease
- Capabilities necessary for data sharing on neuroanatomy and neuromodulation of organ function across the research and technology groups, as well as with the public
How to Submit a Response
To ensure consideration, responses must be received by November 25, 2014, and must be submitted to [email protected].
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:
Jill L. Carrington, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-0671
Email: [email protected]
and Human Services (HHS)
