UMN Awarded $21M Grant for Clinical Study of the Effects of Vagus Nerve Stimulation on Organ Systems

University of Minnesota investigators are leading an intensive global clinical study that aims to establish the effects of vagus nerve stimulation on cardiovascular, metabolic, immune, and autonomic nervous systems. This $21M, 3-year study is funded by the National Center for Complementary and Integrative Health (NCCIH) as part of the NIH’s SPARC initiative (Stimulating Peripheral Activity to Relieve Conditions).

Vagus nerve stimulation (VNS) is currently FDA-approved for the treatment of epilepsy and depression. However, despite the extensive connection of the vagus nerve to different organ systems, the effects of VNS on multiple organs is currently unknown. During this study, subjects with VNS devices will undergo tests measuring the acute and chronic responses of cardiovascular, metabolic, immune, and autonomic nervous systems to determine the effects of various VNS stimulation parameters on these systems. Results will be made publicly available through SPARC’s online platform along with models, simulations, and visualization tools with the goal of optimizing VNS treatments for a variety of conditions. 

Six principal investigators, John Osborn (Surgery), Ziad Nahas (Psychiatry and Behavioral Sciences), Hubert Lim (Otolaryngology), Sayeed Ikramuddin (Surgery),  Lynn Eberly (School of Public Health, Division of Biostatistics), and Vaughan Macefield (Monash University) will be leading this effort. 

This study has been named REVEAL (Research Evaluating Vagal Excitation and Anatomical Links), which is composed of three cores: The Administrative Core, co-directed by John Osborn and Sayeed Ikramuddin of the UMN Department of Surgery, the Clinical Core, co-directed by Ziad Nahas of the UMN Psychiatry and Behavioral Sciences department, Hubert Lim of the UMN Otolaryngology department, and Lynn Eberly of the UMN School of Public Health, Division of Biostatistics, and the Data and Analysis Core, co-directed by Chris Tignanelli of the Department of Surgery, Matthew Johnson of the Department of Biomedical Engineering, and Tay Netoff of the department of Biomedical Engineering. 

This large, multisite study will involve 8 institutions worldwide to aid in subject recruitment, study execution, and data analysis, including the University of Minnesota, The Mayo Clinic (Rochester), Monash University in Victoria, Australia, Stanford University, Washington University in St. Louis, the Medical University of South Carolina, Sheppard Pratt, and Scuola Superiore Sant’Anna in Pisa, Italy. 

Multiple UMN centers are also providing considerable support for this project, including the Institute for Engineering in Medicine, Center for Neuroengineering, and the Minnesota Consortium for Autonomic Neuromodulation.