2024 Call for Pilot Research Applications

NIH U24 Music Networks Pilot Research Applications

In 2023, the National Center for Complementary and Integrative Health (NCCIH) and National Institute on Aging (NIA), with co-funding support from NIH’s Office of Behavior and Social Sciences Research (OBSSR) and National Endowment for the Arts (NEA), funded four music research networks to promote multidisciplinary mechanistic studies of music-based interventions (MBIs) for pain or Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD). These networks are expected to develop compelling research frameworks that will effectively guide future clinical studies on MBIs in the context of these health conditions; adopt consistent terminology and taxonomy; support interdisciplinary collaborations; and initiate 1-year pilot projects to test novel mechanistic hypotheses.

The purpose of the current FOA is to support 1-year pilot studies to generate the necessary preliminary data to strengthen future NIH applications for later-stage studies on mechanisms through which music may have a positive impact on health in the context of pain or AD/ADRD. These pilot studies will also facilitate multidisciplinary collaborations among neuroscientists, music therapists, musicians, and biomedical, behavioral, or social scientists.

Music-based interventions have been investigated for efficacy in the amelioration of symptoms related to acute pain, chronic pain, and AD/ADRD. However, when and how music may influence pain and AD/ADRD are unclear, and little is known about the mechanisms underlying the effects of MBIs.

The scientific scope of the pilot projects is limited to the following high-priority research areas, as outlined in the parent RFA-AT-23-009 for the research networks:

Research Area One
Mechanisms and Biomarkers

1. Exploration of innovative mechanistic hypotheses of the neural systems involved in the therapeutic effect of music (e.g., sensory, motor, cognitive, emotional/affective, reward, interoceptive systems) in acute pain, chronic pain, or AD/ADRD

2. Examination of non-neural physiological systems and novel measures (e.g., impact on related non-neural organs, biochemical and molecular signals, epigenetic modifications) relevant to music or MBIs for acute pain, chronic pain, or AD/ADRD

3. Investigation of psychological, behavioral, and social factors related to the effects of music or MBIs on acute pain, chronic pain, or AD/ADRD (including, but not limited to, predictors, moderators, or mediators of MBI treatment effects)

4. Investigation of psychological, behavioral, and social factors related to the effects of music or MBIs on acute pain, chronic pain, or AD/ADRD (including, but not limited to, predictors, moderators, or mediators of MBI treatment effects)

Research Area Two
Technologies, Tools, & Models

1. Development and/or testing of innovative animal models to study mechanisms and biomarkers of music or MBIs in the context of acute pain, chronic pain, or AD/ADRD

2. Development and/or testing of novel technologies to measure how music or MBIs impact the brain or body, or to monitor health-related responses relevant to acute pain, chronic pain, or AD/ADRD.

Additional Considerations

Note for pilot proposals in the context of pain
For studies involving human subjects, only mechanistic studies, including mechanistic clinical trials, may be appropriate. Studies that are designed to test the safety or demonstrate the efficacy/effectiveness of an intervention should be submitted under the appropriate NCCIH Clinical Trial FOA. Please see NCCIH’s Clinical Trials Funding Opportunity Announcements web page for further information.

Note for pilot proposals in the context of AD/ADRD
NIA utilizes the NIH Stage Model as a conceptual framework for behavioral intervention development and is especially interested in Stage I studies focused on testing the mechanisms through which MBIs may achieve its effects, consistent with the NIH Science of Behavior Change emphasis on mechanisms of change. Information about the NIH Stage Model for Behavioral Intervention Development can be found at: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development. Information regarding NIH’s Science of Behavior Change (SOBC) program can be found at: https://commonfund.nih.gov/behaviorchange.

Note for all pilot proposals
Primary data collection projects are appropriate, but projects must be completed within the proposed 1-year timeline. In such cases, leveraging ongoing studies by adding a study design element, measure, or using a similar approach is strongly encouraged. Secondary data analysis projects are also acceptable but must represent a novel scientific advancement. The proposals cannot include high-risk populations. No data collection for human subjects or animal research in foreign countries is permitted. All pilot applicants should be a member of one of the four networks at the time of submission.

The AudioAnalgesia Network will prioritize applications focused on Research Area One, subarea 1, 2, and 4 and Research Area Two, both in the context of pain.

Eligibility Information

Research scholar affiliated with an accredited University in the United States. Early-stage investigators and under-represented minority candidates are encouraged to apply. Postdoctoral scholars can serve as the PI, but they must include a letter of support from a faculty mentor.

Pilot applications must include multidisciplinary teams.

Applicants are encouraged to register as a member of the network by the time of submission (if they haven’t already done so).

Application and Submission Information

An application (single-spaced, 0.5 margins, and in Arial 11 font) must include the following:

• Cover Page: Include names of principal investigator and other key personnel, institution (for each), mailing address, email, and pilot study title.

• Proposal: Using the required format and 6 pages maximum (excluding literature cited): a) Specific Aims (1 page)

• Significance and Innovation (approximate length: 1 page)
• Approach/Research plan (approximate length: 2-3 pages)
• Environment (approximate length: ½ page)
• Potential for future NIH funding (approximate length: ½ page)
• Literature cited (not included in the page limit)
• Two 1-page maximum letters of support (not included in the page limit)

Preliminary data can be included within the 6-page proposal to support the scientific premise of the study. However, preliminary data are not required, and the absence of it will not be factored into the evaluation.

• NIH Biosketches (non-fellowship) for all key personnel

Budget and Budget Justification

• One-year modular budget in increments of $25,000 but not to exceed $50,000 and a budget justification using the NIH R&R forms. Pilot applications with a budget over $50,000 require prior approval.
• Expenses may include salary and fringe benefits for the PI, co-Investigators and research staff, research supplies, and participant payments.
• Project-related travel expenses are allowed but must occur during the 1-year pilot period.
• Institutional indirect costs and publication costs are not allowed.
• Budgets will need to be approved by NIH if selected for funding.
• Note: A letter of intent is not required.

Submit the application as a single PDF to this secure Qualtrics link:
https://ucsf.co1.qualtrics.com/jfe/form/SV_088inHVs0t8haZw

Evaluation Criteria

The review panel will evaluate the proposals based on:

• Significance: Does the study address an important problem or barrier to progress related to music and pain or AD/ADRD research?

• Innovation: Does the proposal include novel concepts, approaches, or methods that will advance knowledge about music and pain or AD/ADRD research?

• Investigator(s): Do the principal investigator and co-investigators have the background necessary to complete the project? Does the proposal involve collaborators from multiple disciplines? Does the principal investigator have the expertise and experience to lead the proposal?

• Approach: Are overall methods, study design, analyses, or planned activities appropriate and feasible to be completed within the award period?

• Environment: Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project? Will the project benefit from unique features of the environment, participant populations, or collaborative arrangements?

• Future potential: Does the proposal have potential to help expand the research network? Is the proposal likely to lead to future NIH funding, and has the applicant clearly articulated future plans stemming from this project?

Review and Selection Process

Applications will be reviewed by all four Music Network teams and also require approval from NIH. The selection of pilot projects will be made in consultation with the NIH Project Scientist(s) and approved by the NIH Program Officer(s).Selected pilot applications will be requested to submit additional materials for further consideration and to conform to NIH funding requirements

Final Report
• A final report at the conclusion of the pilot study will be required.

Key Dates
• Posted date: July 22, 2024
• Date due: accepting applications through October 1, 2024 (5pm Pacific standard time) Projected start date of pilot funding: Summer 2025

Research Network Contacts

AudioAnalgesiA
Debra Burns, PhD (PI)
Website: https://audioanalgesia.org
audioanalgesia@memphis.edu