Key Dates

Related Announcements

Issued by

National Center for Complementary and Integrative Health (NCCIH)

National Institute on Aging (NIA)

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), and National Institute for Neurological Disorders and Stroke (NINDS) are requesting information to guide a National Institutes of Health (NIH) effort, in partnership with the Foundation for the National Institutes of Health (FNIH) and the Renée Fleming Foundation, on “Developing Evidence-Based Music Therapies for Brain Disorders of Aging.” The project aims to develop, validate, and disseminate a toolkit for music-based intervention protocols that researchers will be encouraged to use in NIH-funded interventional studies.

On March 31, 2021, NIH, in collaboration with FNIH and the Renée Fleming Foundation, hosted the inaugural event for the project through the public workshop “Laying the Foundation: Defining the Building Blocks of Music-Based Interventions.” The next workshop, to be hosted on June 18, 2021, will address “Assessing and Measuring Target Engagement: Mechanistic and Clinical Outcome Measures for Brain Disorders of Aging” and will be followed by the final workshop hosted on August 25, 2021, “Relating Target Engagement to Clinical Benefit: Biomarkers for Brain Disorders of Aging.”

This Request for Information (RFI) is to notify stakeholders about the process for providing input.

Responses must be received by June 30, 2021, to be considered.

NIH invites input from stakeholders, experts, communities, and members of the public, including but not limited to researchers and trainees across academia, industry, and government; health care providers and health advocacy organizations; nongovernmental, scientific, and professional organizations; and Federal agencies.

Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole.

Current music and health research toolkit themes:

• Importance of conceptual frameworks for music-based interventions
• Design and responsibilities of the investigative team
• Rigorous and reproducible experimental design
• Metrics to track mechanistic and clinical outcomes
• Methodological and trial design issues

Submit your comments using the online comment form at: https://www.nccih.nih.gov/request-for-information-inviting-comments-on-developing-evidence-based-music-therapies-for-brain-disorders-of-aging.

Alternatively, responses may be sent to [email protected].

Please comment on any (or all) of the following topic areas (responses are limited to 250 words):

• When designing music-based interventions, identifying all the details/aspects of the intervention may not be possible, but some aspects of music may need to be standardized to compare results across different studies. Identify the most important details/aspects (e.g., timing, dosing, music type, patient’s musical experience) to be standardized.

• Neurological systems interrelate and interact, and an intervention is likely to affect multiple systems. Describe how a study could be designed to achieve a balanced approach toward targeting specific systems (e.g., autonomic nervous system, motor domains, sensory domains, cognitive domains) and system interactions. Identify the primary domains to be included and any other details that should be captured.

• Examining the potential influences/confounders (e.g., interpersonal interactions, therapist effects, motivation/engagement) of the music-based intervention on targeted clinical outcomes is important. Identify the most important potential influences/confounders of the intervention that should be considered when assessing clinical outcomes. Include any existing standardized measures that should or could be used for these assessments.

• Describe the potential biomarkers and tools that would be most useful for assessing the effects of music interventions and for demonstrating target engagement and changes in biological effects. Examples include: neural correlates/relevant brain systems biomarkers as measured by functional magnetic resonance imaging (fMRI), clinical electrophysiology, emotional reactivity, or neurocognitive performance; ecological momentary assessments as measured by sensor or mobile technologies; markers of nonverbal communications between subjects and therapist as measured by field evaluation; and blood or cerebrospinal fluid biomarkers or retinal or skin responses as measured by biometric tools.

• Provide any additional comments or suggestions relevant to this RFI.

Note: For your recommendations, please consider indicating appropriate, objective success criteria, including quantitative and qualitative benchmarks and milestones for gauging progress in the corresponding area.

NIH also welcomes your general comments, including those regarding the extent to which NIH has guided and encouraged the field.

Responses are voluntary and may be submitted anonymously. Each comment received in response to this RFI will be considered in aggregate as part of the overall toolkit development. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Please do not include any personally identifiable or other information that you do not wish to make public. No proprietary, classified, confidential, or sensitive information should be included in your response.

This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States Government. NIH will not make any awards based on responses to this RFI or pay for the preparation of any information submitted or for the Government’s use of such information.

Inquiries

Please direct all inquiries to:

Name: Dave Frankowski, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-594-7639
Email: [email protected]