Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required) | PAR 23 256

Opportunity Information: Apply for PAR 23 256

The National Institutes of Health (NIH) funding opportunity PAR-23-256, titled "Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)," supports early-stage, proof-of-concept clinical trials that test music-based interventions for brain disorders commonly associated with aging. The central aim is to fund feasibility studies that are explicitly guided by the NIH Music-based Interventions (MBI) Toolkit, using that toolkit's principles to shape how the intervention is designed, delivered, and evaluated. These projects are meant to do the practical early work needed before a larger and more definitive trial can be launched, and they are expected to produce pilot data strong enough to support a later clinical efficacy, effectiveness, or pragmatic clinical trial.

The opportunity focuses on brain disorders of aging, including (but not limited to) Alzheimer's disease and Alzheimer's disease-related dementias, Parkinson's disease, and stroke. Applicants are expected to use the feasibility trial to address important scientific or methodological gaps that currently prevent the field from moving confidently to large-scale testing. In practice, that means studies should not only ask whether a music-based intervention can be delivered to the target population, but also whether it is acceptable to participants, safe, implementable in realistic settings, and measurable with outcomes and procedures that will translate cleanly into a subsequent, larger trial. A key expectation is that the results will help validate or refine the guiding principles laid out in the NIH MBI Toolkit, rather than treating the toolkit as optional background material.

Because this is an R34 mechanism and the NOFO specifies "Clinical Trial Required," the funded projects must include a clinical trial component. The role of the feasibility trial is to de-risk the next step by generating the kind of operational and scientific evidence reviewers typically look for when considering a full-scale study. That can include details like recruitment and retention performance in older or neurologically impaired populations, adherence to the intervention over time, fidelity monitoring for the music-based protocol, the practicality of the control or comparison condition, and preliminary signals that selected outcomes are sensitive and appropriate. The overall emphasis is on building a credible foundation for a later, competitive application proposing a larger trial.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, 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; Native American tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside higher education); for-profit organizations other than small businesses; and small businesses. The NOFO also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal government agencies, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

At the same time, the announcement draws clear boundaries around foreign involvement. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may be able to include certain foreign elements in the project if they meet NIH's definition and requirements for a foreign component.

Administratively, this is a discretionary grant opportunity from the NIH under CFDA numbers 93.213 and 93.866. The opportunity was created on August 7, 2023, with an original closing date listed as December 21, 2023. The provided source data does not specify an award ceiling or the expected number of awards, so applicants would typically need to consult the full NOFO and any linked NIH Institute or Center guidance for budget expectations, project period norms, and review considerations.

• The National Institutes of Health in the regional development sector is offering a public funding opportunity titled "Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.866.
• This funding opportunity was created on 2023-08-07.
• Applicants must submit their applications by 2023-12-21. (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 PAR 23 256

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