NCCIH Research Blog

Growing evidence shows that music engages many areas of the brain and may strengthen neural pathways involved in emotion, affect, memory, and sensorimotor processes. Music-based interventions (MBIs) have shown promise for helping manage symptoms of brain disorders of aging, such as Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD), Parkinson’s disease (PD), and stroke. However, much of the evidence obtained so far is anecdotal or comes from small studies.

The National Institutes of Health (NIH) Music-Based Intervention Toolkit, adapted from a paper published in Neurology in May 2023, is designed to provide guidance for rigorous, reproducible clinical trials of MBIs for brain disorders of aging. The toolkit is an outcome of a series of workshops held in 2021 by NIH, in collaboration with the Foundation for the NIH and the Renée Fleming Foundation. The workshops brought together experts from neuroscience, music therapy and music medicine, behavioral intervention development, clinical trial methodology, and patient advocacy and arts-based organizations to discuss the essential elements for high-quality research on MBIs.

It’s time now to take the toolkit out for a test drive—and get data to support future large-scale studies at the same time.

The National Center for Complementary and Integrative Health (NCCIH) and National Institute on Aging (NIA) have released a notice of funding opportunity (NOFO), Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R24 Clinical Trial Required) (PAR-23-256), to support proof-of-concept trials guided by the NIH MBI toolkit. These trials will produce evidence on the validity of the toolkit’s guiding principles as well as pilot data for subsequent full-scale efficacy, effectiveness, or pragmatic clinical trials with the potential to have a significant impact on public health. 

Proposals submitted in response to this NOFO must:

• Propose an early-phase feasibility clinical trial of an MBI for a brain disorder of aging (such as but not limited to AD/ADRD, PD, or stroke).
• State a conceptual framework and address all the MBI building blocks outlined in the toolkit.
• Identify relevant clinical outcomes and/or biomarkers.
• Propose a multidisciplinary research team; patient/caregiver engagement is also encouraged.

Projects that are not appropriate for this NOFO include:

• Trials that propose estimating an effect size or preliminary efficacy, either as a primary or exploratory aim.
• Studies that don’t include a primary feasibility or acceptability outcome.
• Phase III trials of efficacy or effectiveness.
• Observational studies.
• Studies that don’t use the guiding principles of the NIH MBI toolkit.

Upcoming application deadlines are February 20, 2024 and June 20, 2024.

NCCIH and NIA will hold a technical assistance webinar on Tuesday, December 19, 2023, from 2 to 3 p.m. ET, to explain the funding opportunity and answer questions. Although participation is optional, I encourage you to register and join us so you can find out more about this unique and exciting funding opportunity.

For More Information

• Read the NOFO: Feasibility Trials of the NIH Music-based Interventions Toolkit for Brain Disorders of Aging (R24 Clinical Trial Required) (PAR-23-256).
• Register for the December 19 technical assistance webinar.
• Looking for inspiration? Attend the virtual workshop Music as Medicine: The Science and Clinical Practice on December 14 and 15. This event is sponsored by NIH and the National Endowment for the Arts (NEA) and jointly organized by NIH, the NEA, the Renée Fleming Foundation, and the John F. Kennedy Center for the Performing Arts. Register now.