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

The NIH’s “Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R34 Clinical Trial Required)” supports early-stage clinical trials to explore the feasibility of music-based interventions (MBIs) for brain disorders associated with aging. This reissue of PAR-23-256 funds projects that aim to validate the NIH Music-based Interventions Toolkit by generating pilot data that will inform larger-scale efficacy studies. The trials must examine whether the MBI’s guiding principles are feasible in the context of Alzheimer’s disease, related dementias, Parkinson’s disease, and stroke. Importantly, the focus is on feasibility rather than efficacy, with a strong emphasis on adhering to the NIH MBI Toolkit’s framework, which ensures rigorous and reproducible outcomes essential for progressing toward clinical integration. The primary objective of this NOFO is to address critical research gaps in music and brain health by supporting the creation of robust, scientifically validated feasibility data. Feasibility trials are encouraged to evaluate the MBI Toolkit’s conceptual frameworks, intervention elements, and delivery methods. Acceptable trial goals may include assessing feasibility across various patient populations and stages of disease progression, exploring adherence and acceptability, and testing protocol elements necessary for future multi-site efficacy studies. This initiative is particularly relevant given music’s potential to impact brain function positively and the need for rigorously gathered data in this field. Funding under this NOFO allows for up to $450,000 in direct costs over a maximum three-year project period, with no more than $225,000 allowed in any given year. Eligible applicants include higher education institutions, nonprofit organizations, for-profit entities, and specific government agencies, among others. Although applications from non-U.S. entities are not permitted, foreign components can be part of U.S.-based organizations’ applications. The NIH does not require cost sharing for this grant, and organizations may submit more than one application provided each is scientifically unique. The application process mandates alignment with the NIH MBI Toolkit, detailing project significance, innovation, and feasibility objectives. Proposals must define the MBI’s conceptual basis, specify clinical outcomes or biomarkers, and justify the comparator group within a randomized controlled design. Additionally, the grant application must include multidisciplinary expertise in clinical trial design, music therapy, behavioral science, and neuropsychology. Applicants are also required to submit a Data Management and Sharing Plan, following NIH’s updated policy guidelines. Key dates for submission include a letter of intent due 30 days before the application deadline, with the earliest open submission on May 20, 2024, and multiple review cycles available through October 21, 2024. All applications must be submitted through Grants.gov or NIH’s ASSIST system and conform to detailed formatting and content guidelines. Prospective applicants are advised to complete necessary registrations, such as in the System for Award Management (SAM) and eRA Commons, well in advance. Evaluation criteria focus on significance, innovation, approach, and adherence to NIH MBI Toolkit guidelines, with applications assessed for their feasibility in transitioning to full-scale trials. Trials focused solely on efficacy, safety, or repetitive feasibility studies with similar interventions and patient demographics are deemed non-responsive. Additionally, applications lacking a music-based intervention, proposing multi-site physical intervention delivery, or including waitlist controls will not be considered.