SPARC VNS Endpoints from Standardized Parameters (VESPA) (U54 Clinical Trial Required) | RFA RM 22 002

Opportunity Information: Apply for RFA RM 22 002

The SPARC VNS Endpoints from Standardized Parameters (VESPA) funding opportunity (RFA-RM-22-002) is a National Institutes of Health (NIH) cooperative agreement designed to support a single U54 Research Center that will run a large, multi-site clinical study focused on vagus nerve stimulation (VNS) in humans. The central idea is to test a standardized range of VNS stimulation settings and carefully measure how those settings affect multiple organs and body systems, not just one target symptom or condition. By doing this in a structured, comparable way across sites, the project aims to generate a clearer map of how VNS influences systems-level human physiology and, more broadly, how the vagus nerve functionally connects to different organ systems.

A key deliverable is a high-quality, publicly shared dataset that captures the multi-organ endpoints produced by VNS across standardized parameter choices. The expectation is that these shared data will help the broader research and clinical community move toward more evidence-based optimization of VNS therapy, including understanding which stimulation settings are associated with specific physiological responses and which responses may be beneficial or undesirable. In practical terms, the award is meant to produce a reference-grade resource: a rigorous, multi-site human study that can inform future VNS research, device programming strategies, and potential therapeutic uses by showing the broad functional impact of VNS on systems physiology and clarifying aspects of human vagal functional connectivity.

This announcement uses a cooperative agreement mechanism (U54), which typically means NIH will have substantial scientific or programmatic involvement during the project compared to a standard research grant. The activity category is listed as Health, and the CFDA number provided is 93.310. The opportunity is explicitly labeled “Clinical Trial Required,” indicating that applicants must be prepared to conduct a clinical trial as part of the proposed work rather than only planning preclinical, observational, or purely methodological efforts.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations (not federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments other than federally recognized entities.

At the same time, the FOA draws clear boundaries around non-U.S. participation. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed when they meet the NIH Grants Policy Statement definition, which typically means discrete project elements may be performed outside the U.S. under an eligible U.S. applicant organization when well-justified and compliant with NIH policy.

Key administrative details included in the source information are that the sponsoring agency is the National Institutes of Health, the funding instrument type is a cooperative agreement, and the original closing date listed was April 1, 2022 (with the opportunity record created on December 14, 2021). The listing does not provide an award ceiling or expected number of awards in the provided excerpt, but it frames the effort as a U54 Research Center supporting a large, multi-site clinical study with an emphasis on standardized VNS parameter testing, multi-organ endpoint measurement, and rapid public sharing of the resulting data to accelerate optimization and understanding of VNS in humans.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "SPARC VNS Endpoints from Standardized Parameters (VESPA) (U54 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2021-12-14.
• Applicants must submit their applications by 2022-04-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA RM 22 002

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