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Nonpharmacologic approaches, such as music, for treating and managing symptoms of brain disorders are currently of interest to patients and investigators. Music may help strengthen the brain pathways involved in sensory and motor processes, emotion, affect, and memory. Many of these functions are affected by brain disorders of aging. Therefore, music-based interventions (MBIs) can be helpful as inexpensive, noninvasive, and accessible therapeutic strategies. However, well-powered studies are required to fully understand how music affects the brain and its therapeutic potential. To be able to reach specific conclusions, consistency in study designs, procedures, and measures is necessary. The NIH MBI Toolkit is made to promote consistency in MBI studies.
For MBIs to fulfill their potential, the studies on them must become more rigorous and replicable. This will require the development of standards and tools that can be applied to interventional studies. Therefore, using the guidelines in the NIH MBI Toolkit is strongly recommended, especially for NIH-funded studies on MBIs.
Music-based interventions (MBIs) show promise for managing symptoms of various brain disorders. To fully realize the potential of MBIs and dispel the outdated misconception that MBIs are rooted in "soft science," the National Institutes of Health (NIH) is promoting rigorously designed, well-powered MBI clinical trials. The pressing need of guidelines for scientifically rigorous studies with enhanced data collection brought together the Renée Fleming Foundation, the Foundation for the NIH, the Trans-NIH Music and Health Working Group, and an interdisciplinary scientific expert panel to create the NIH MBI Toolkit for research on music and health across the lifespan. The Toolkit defines the building blocks of MBIs, including a consolidated set of common data elements for MBI protocols, and core datasets of outcome measures and biomarkers for brain disorders of aging that researchers may select for their studies. Utilization of the guiding principles in this Toolkit will be strongly recommended for NIH-funded studies of MBIs.
NIH Music-Based Intervention Toolkit: Music-Based Interventions for Brain Disorders of Aging
Neurology 2023 Jan 13;[EPub Ahead of Print], E Edwards, C St Hillaire-Clarke, DW Frankowski, R Finkelstein, T Cheever, WG Chen, L Onken, A Poremba, R Riddle, D Schloesser, CE Burgdorf, N Wells, R Fleming, FS Collins
In recent years, a growing body of medical literature has described various benefits of music-based interventions (MBIs) for human health. However, the relatively low quality of the research published to date has slowed the development of this field of inquiry. The article by Edwards et al presents a framework (NIH Music-Based Intervention Toolkit) for studies that use MBIs to promote human health, with a focus on diseases of aging, including Parkinson's disease, Alzheimer's disease and related dementias, and stroke. It is the culmination of a multi-year effort from the Trans-NIH Music and Health Working Group, the Foundation for the NIH, the Renée Fleming Foundation, and an interdisciplinary scientific expert panel to create guidelines for research on music and health that would meet the rigorous standards required for NIH-funded studies. The toolkit defines the building blocks of MBIs, including a set of common data elements for MBI protocols, core datasets of specific outcome measures, and biomarkers that can be included in future studies. The authors note the importance of evaluating the impact of the MBI on multiple domains and thinking carefully about the intervention type, mode of delivery of the intervention, the target population, the study design, and data collection and management. An important and often challenging aspect of clinical trial development is the selection of appropriate control groups, and the authors advise using the Pragmatic Model for Comparator Selection in Health-Related Behavioral Trials1 to help in this regard. In addition, for the selection of appropriate study outcomes, the Patient-Reported Outcomes Measurement Information System (PROMIS)2 and the NIH Toolbox3 can complement the NIH MBI Toolkit and are freely available online. Finally, the authors emphasize that a team science approach is required to successfully complete an impactful MBI study and describe key members of interdisciplinary MBI study teams.
Highlighting the promise of MBIs for human health, the authors note that “MBIs have the potential to influence patient-relevant target outcomes, such as manage symptoms, slow disease progression, rehabilitate, and improve the quality of life in many disease conditions across the lifespan.” This effort represents an important step toward advancing the fields of music medicine and music therapy in the twenty-first century and beyond.