Stimulating Peripheral Activity to Relieve Conditions (SPARC)
Stimulating Peripheral Activity to Relieve Conditions (SPARC)
Frequently Asked Questions
Click on the drop-down menus to open and close the Frequently Asked Questions specific to each funding opportunity listed below.
Archived Funding Opportunities
Scope/Approach
1. How is it possible to separate the effects of vagal nerve stimulation to treat specific diseases?
The SPARC program aims to understand how to stimulate the vagus to reach therapeutic endpoints without off-target effects. We aim to understand the anatomical organization of the vagus nerve in order to understand the feasibility of selectively targeting a sub-part of the nerve to treat a specific disease.
2. How extensive may we propose to characterize the detailed anatomy of nerve branches from the vagus to specific organs?
This is of interest to SPARC to the extent that it does not dilute our effort to understand the main trunk, branch points, or other potential target neuromodulation sites of the vagus.
3. What techniques are you envisioning to be used in this project?
We purposefully did not specify techniques in the solicitation and leave this open to investigators to propose specific approaches. Imaging across large lengths of the nerve may be combined with imaging thin cross sections to characterize the anatomy more in-depth.
4. Different techniques will offer different scales with different resolutions. Performing sectioning for these different techniques may not be possible across the entire vagus nerve. Is it possible isolate specific locations of interest of the vagus nerve for sectioning by larger and smaller scale micro-sectioning techniques rather than across the entire vagus nerve sample?
Yes. We recognize that isolation of different vagus locations of interest and using various solutions of different scales together may be necessary.
5. How many vagal specimens should be obtained and analyzed? For the deliverable requiring “100 human vagal samples”, is that 100 humans or 50 humans left/right?
Offerors should include the breakdown of the 100 human vagal samples in their proposal, providing scientific and statistical justifications for the target numbers. The number and types of vagal specimens obtained should be scientifically justified and statistically powered to inform accurate circuit-level schematics that reflect variability across sexes and age groups, and variability between the left and right vagus.
6. Other than microCT, which is mentioned in the solicitation, can other experimental techniques be used to image and characterize the vagal specimens?
Yes, as long as image resolution is sufficient to allow segmentation and tracking of nerve fascicles and organization along the length of the nerve and across branch points. Complementary experimental techniques can be used to characterize axon, fascicle, and nerve properties, such as the type and size of axons, myelin, epineurium, and perineurium; if afferent or efferent based on neurochemical or microtubule characteristics; neurochemical phenotype, etc.
Budget
7. A budget cap is not listed in the RFP – is there a limit?
Budgets should reflect the estimated costs of the work proposed.
8. Does the SPARC DRC (DAT-Core and K-Core) need to be included in the proposed budget for their data sharing and curation services?
No. The SPARC DRC will remain available to support data sharing and curation of data generated by SPARC awardees in phase 2 of the program, pending availability of NIH funds.
Formatting
9. Is the 20-page limit for the Technical Discussions section inclusive of reference pages?
References may be appended outside of the 20-page limit.
10. Is the 100-page limit on the technical proposal inclusive of personnel resumes?
Resumes or biosketches may be appended and not included in the 100-page limit, but the description of the experience and qualifications of key personnel should be described within the 100-page limit of the technical proposal.
11. Is the 100-page limit on the technical proposal inclusive of the attachments in section J?
No.
12. Can NIH biosketches be used as resumes?
Yes.
13. Should the solicitation attachments be included as attachments in our response documents to NIH (assuming no)?
No.
14. Does the 2-week COVID Extension for grants also apply to contracts?
No, the deadline is April 4, 2022, at 3pm ET.
General
1. What is the goal of the SPARC program's VNS Endpoints from Standardized Parameters (VESPA) initiative?
The goal of this initiative is to examine the multi-organ effects of cervical vagal nerve stimulation (VNS) in humans, producing a first-of-its-kind data set that will be shared rapidly and broadly. These data will contribute to the optimization of VNS treatment by providing a multi-system view and assessment of the variability of the vagus nerve’s functional connectivity in humans, filling a critical knowledge gap.
2. What is a VESPA Center?
This initiative plans to support one VESPA Center to administer and coordinate clinical studies that will document and analyze the physiological outcomes of VNS in study participants. The Center will consist of multiple Core functions (Administrative, Clinical, and Data & Analysis Cores) and optional Ancillary Project(s). For a full description of VESPA Center activities, please see RFA-RM-22-002.
3. What are ‘Optional Ancillary Projects’?
Optional Ancillary Projects could include proposals to add stimulation targets and modalities for comparison to cervical VNS (e.g. auricular nerve stimulation, thoracic vagal nerve stimulation, non-invasive or transcutaneous nerve stimulation) and/or additional outcome measures.
4. How many organ systems need to be included in an application to this funding opportunity (RFA-RM-22-002)?
Each application must propose to study at least three distinct peripheral organ systems for outcome data collection, and a scientific justification must be provided for those outcomes.
5. Will there be additional receipt dates for applications to this initiative?
No. At this time the ONLY receipt date for this funding opportunity (RFA-RM-22-002) is April 1, 2022.
6. Can a single group/entity fulfill multiple core functions? Are there any requirements on minimum or maximum number of parties involved?
There are no requirements or limitations on a single institution running one or more cores or ancillary projects.
7. What is the expectation on optimizing stimulus parameters?
We do not anticipate optimizations for a therapeutic effect happening within the current VESPA funding opportunity. The main goal is to understand the functional connectivity, which we anticipate will eventually lead to the larger goal of optimizing treatments. We ask that you propose to look at the timing and methods of outcome measures to reflect that goal.
8. What are the guidelines for collaborating with industry partners?
There are no limitations on partnerships.
9. Is there any expectation on the type of devices used in this study?
We expect to see stimulation on the cervical vagus nerve. It is ideal if you can use the same device across participants; however, if you can show that this can be achieved through multiple devices and how data across participants with multiple devices may be combined, this will also be considered.
10. Is it possible to perform standardized measurements in different subgroups of existing or newly recruited patients, each with a different organ system study of interest?
All participants for the main study need to undergo the Common Study Protocol containing measures across a minimum of three organ systems; all subsequent studies would be considered part of an Ancillary Project. Due to the limited size of the eligible patient population, it is strongly preferred that Ancillary Projects do not recruit from outside of the Common Study Protocol participant population. Applicants may propose Ancillary Projects that enroll additional participants who are not enrolled in the Common Study Protocol, but strong justification must be provided for doing so, including strong rationale for methods of direct comparisons to Common Study Protocol data.
11. Should studies focus on specific organs or organ systems?
Studies of organ systems, not just connectivity to organs, would be appropriate. There is no preference for any particular organ system as long as the requirements for measurements from three separate organ systems are made as part of the Common Study Protocol.
12. Should acute versus chronic studies be considered in proposals?
The goal of VESPA is to understand the connectivity and not a therapeutic effect; therefore, clinical relevance is not necessarily beneficial to the proposal. Applicants should consider the scientific timing of measures for the targeted organ systems and measurement protocols. Different organ systems may require different timing based on the natural processes of the targeted system.
13. What is the goal of the team building webinar?
Because VESPA studies may require different expertise and recruitment of participants from multiple sites, we aim to provide a place for individuals from different backgrounds to interact and potentially form partnerships to bolster their studies.
14. Where can I find out more about this initiative?
The SPARC program held two informational webinars and one team-building webinar in early 2022 for the SPARC VNS Endpoints from Standardized Parameters (VESPA) funding opportunity announcement (RFA-RM-22-002). Webinar slides are available on the Scientific Meetings webpage. Keep up to date with the latest news by checking the SPARC website regularly and signing up for the SPARC listserv. Questions about the SPARC VESPA initiative (RFA-RM-22-002) can be emailed to [email protected].
1. What is the goal of the SPARC program's HORNET initiative?
The goal of the HORNET initiative (RFA-RM-21-024) is to advance the clinical translation of peripheral neuromodulation therapies in humans (with potential applicability in the central nervous system as well). To accomplish this goal, the HORNET initiative plans to support the development of open-source libraries that provide “templates” describing combinations of individual technology modules necessary to construct complete, fully functional neuromodulation systems for use in human clinical research.
2. Can HORNET Center applications include clinical trials?
No, clinical trials are not allowed. You should use this NIH clinical trial decision tool if you need help determining whether or not your planned human subjects research is considered a clinical trial.
HORNET Center applications should be geared towards validation activities and focused on the development of preclinical technologies to the point of validation in animal or computational models, or both. A usability study or survey of patients could be acceptable; however, no interventional studies in humans should be included in HORNET Center applications.
3. What are some examples of non-responsive activities for the SPARC HORNET initiative?
Applications that include the following activities will be considered non-responsive, will be withdrawn, and will not be reviewed:
- Development of new animal models
- Development of new proprietary technologies
- Development of modules intended only for animal use
- Development of technologies for augmentation of healthy individuals
- Development of technologies that lack any potential use as elements of a neuromodulation system acting in the peripheral nervous system or spinal cord to modulate electrical activity to improve organ function
- Clinical evaluation of safety and effectiveness
4. Can you explain what the non-responsive activity, “Development of new proprietary technologies,” refers to?
“Development of new proprietary technologies” refers to any new technologies with Intellectual Property (IP) Protection(s) or other restrictions that would prevent them from being freely shared and used. Applications that include development of “new proprietary technologies” will be considered non-responsive for this funding opportunity.
The modular technologies and neuromodulation system designs developed under the HORNET Centers must be open-source and available to the research community. If something is invented as part of a HORNET Center project, it is expected to be shared freely and openly and not be protected by IP.
5. Is collaboration with industry required to achieve the goals of the HORNET initiative?
No, collaboration with industry is not required. Types of collaborations are not defined by this initiative (RFA-RM-21-024). Applicants may collaborate with other institutions, industry, or contractors. However, projects should be developed with an eye towards meeting testing and manufacturing requirements in alignment with FDA regulations/expectations.
6. Are there limitations on collaborations across institutions?
No, there are no limitations on collaborations across different institutions. However, only the primary HORNET Center institution can receive the HORNET Center award. The primary institution may issue sub-awards or contracts to collaborating institutions.
7. Do HORNET Center NEST projects have to be designed for organ-specific applications?
No, proposed neuromodulation systems should be designed with the ability to be used for different peripheral applications, so they do not have to be tailored toward one specific organ or organ system. Projects may include applications to a specific organ system, but the technology should also be applicable to other organs in the periphery by making modifications to the system. Adaptations making the system applicable to the central nervous system may also be considered.
8. What are the page limits for the NEST projects?
The page limit is 6 pages per NEST project. There is a required minimum of 3 and maximum of 5 NEST projects per HORNET Center application. You may not shift page limits between NEST projects. For example, if an application includes 3 NEST projects, the page limit is 18 pages with a maximum of 6 pages per NEST project.
9. Is there a core software technology that all HORNET awardees should use?
No, teams may choose software technology(ies) appropriate for their Center. As stated in RFA-RM-21-024, “…emphasis should be placed on producing portable, well-documented, user-friendly software that is readily available and has user support.”
10. Can components or software that are not open-source still be used by HORNET Center?
Maybe, depending on the situation. The documentation and design libraries that are released by your Center should contain sufficient information such that another investigator could independently recreate your modular technologies and neuromodulation systems. If you have additional questions, please email the HORNET program team at [email protected].
11. Will there be any opportunity to patent the technologies developed in a HORNET Center project?
Maybe, depending on the situation. The modular technologies and neuromodulation systems developed under a HORNET Center are required to be open source (i.e., not patent protected or kept as trade secrets), and the resulting design libraries will be shared publicly as part of a HORNET Center project. After the public dissemination of these materials, it is possible that a combination of modular technologies into a functional neuromodulation system for application to a specific indication could be patented.
12. Is there a specific open-source licensing scheme that hardware and software will need to follow?
No, a specific open-source licensing scheme is not required. There are examples provided in RFA-RM-21-024 (e.g., Creative Commons, MIT, Apache 2.0, or BSD), but applicants are not required to use these specific examples.
13. Is it up to the end user to meet all of the final regulatory requirements?
Yes.
14. Should the focus of my application be on development of technology modules or on validation studies?
Both the development of open-source technology modules and technology validation studies using model systems (benchtop, computational, and/or existing animal models) should be included in an application to RFA-RM-21-024. For examples of suggested milestones that could be included in an application, please see the PHS 398 Research Plan section of RFA-RM-21-024.
15. Can I send you my specific aims page prior to final submission to see if it fits with requirements of the RFA?
Yes, please email the SPARC HORNET program team at [email protected].
16. Where can I find out more about the SPARC HORNET Initiative?
A recorded informational webinar and slides are available on the SPARC program Scientific Meetings webpage. Keep up to date with the latest news about the SPARC HORNET Initiative and the SPARC program by checking the SPARC website regularly and signing up for the SPARC listserv. Questions about the SPARC HORNET initiative can be emailed to [email protected].
1. What is the Neuromod Prize?
The Neuromod Prize is a 3-phase $9.8 million competition to accelerate the development of targeted neuromodulation therapies. The first phase calls on scientists, engineers, and clinicians to submit novel concepts and plans for groundbreaking uses of peripheral nerve stimulation that can independently regulate two or more desired autonomic functions without unintended effects on non-target organs.
A judging panel will select up to eight winners to receive a share of the up to $800,000 Phase 1 prize pool. Phase 1 winners will be exclusively invited to participate in future phases, anticipated to take place in 2022 and beyond. Phase 2 will have a total potential prize pool of $4 million. Phase 3 will have a total potential prize pool of $5 million.
Learn more at neuromodprize.com.
2. How can I learn more about this competition?
Learn more about the Neuromod Prize in the press release and program Highlight. You can also visit neuromodprize.com to get an overview of the competition, see highlights from the February 7 virtual information session, and keep up with the latest news.
We appreciate your interest in the Targeted Needs to Achieve SPARC Program Goals (OTA-20-004) Funding Opportunity and hope that you and your team will choose to submit an application. In order to maximize your chances of success, we would like to provide some guidance that may be helpful as you put the finishing touches on your application:
- Please view information about the o2S2PARC platform, including an informational webinar, platform documentation and demos that are available on the SPARC - FOA Priorities page.
- For clarification of the Priority, we encourage you to submit your questions to [email protected].
1. What does it mean for a simulation to be interoperable?
Simulations should not run in isolation but rather should be capable of coupling to other simulations within the o2S2PARC platform. For example, SPARC is already funding development of models that predict activation or block of autonomic nerves based on a given electrode design and stimulus paradigm. Models developed under this Priority could take those activation or block profiles as input and predict how they impact organ physiology.
2. What does it mean for a simulation to be personalizable?
Simulations should be designed to allow for user-defined input parameters that correspond to variables that could be assessed in individual humans as part of near-future clinical care. For example, nerve thickness, body mass index, resting heart rate, organ dimensions, etc.
3. Can my proposed project focus on a disease or condition of my choice?
Yes, as long as that disease or condition relates to the stomach, colon, lungs, heart, or lower urinary tract.
4. How and why should I incorporate the Ten Simple Rules for Model Credibility into my planning?
Proposals must describe how the simulations to be built will be amenable to evaluation with the Ten Simple Rules for Model Credibility, developed in the IMAG Multiscale Modeling Consortium. Not all ten rules need to be tested in the plans, but proposals should explain how simulations should provide the types of outputs or documentation that would be needed to do so. For example, with respect to validation, simulations must clearly expose the extent of verification, validation, and uncertainty of each parameter choice or relationship assumption, and thereby provide guidance to the relevant experimental community on where new experimental data could be most impactful.
Planning for evaluation with the Ten Simple Rules creates a path to credibility within the intended context of use, fostering confidence, adoption and re-use for an analytical tool. View an example of thinking through the rules as they apply to a model generated by NASA scientists to predict bone fracture in space.
5. How can I gain access to the o2S2PARC platform?
Please send an email requesting access to [email protected].
6. Can proposed projects have any data collection components, or should they be wholly theoretical?
New experimental data can be collected, but existing data should be utilized to the maximum extent possible.
7. Is use of SPARC experimental data required?
No. Any existing experimental data can be utilized, whether from SPARC or elsewhere.
8. How should my application account for work that involves collaborating with the IT'IS Foundation?
Proposed projects that require technical assistance and support from the IT’IS Foundation should state so in their applications. In cases where significant levels of effort (beyond technical support) are requested from the IT’IS Foundation, applications should describe the work to be performed by the IT'IS Foundation, and a letter of support from the IT'IS Foundation should be included. When only basic assistance/support is requested, letters of support from the IT’IS Foundation should not be included. Your budget should not account for work that will be performed by the IT'IS Foundation; if necessary, SPARC has the ability to support that work separately through award OT3 OD 025348.
9. Can you explain the requirement that projects should strive to make an impact on neuromodulation therapy development within the next 1-4 years?
Proposed projects should have a goal to inform therapy development in a manner that can begin to be tested clinically within 4 years of the project commencing. Projects are not expected to perform clinical validation on their own. However, knowledge or predictions that result from a project should take a form that enables them to be tested in a clinical setting by others.
10. To what extent can projects generate new experimental data?
The motivation behind this Funding Priority is to leverage the vast amounts of experimental data that already exist. The focus of projects should be to tap into those data for building predictive simulations that inform neuromodulation interventions. Generation of new data is allowable, but applications should justify why new data are needed. Examples could include filling in gaps where data do not currently exist or performing experiments to validate the models.
