REVEAL Study Begins Enrollment of Participants

Recently, REVEAL achieved a major milestone in that enrollment of participants in the CSP began. The first enrollment was at the University of Minnesota.

Sparc news

Published Date

July 24, 2024

External Link

https://sparc.science/about/projects/12Sx14yHIItQQtfIl2YrID

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The University of Minnesota is leading REVEAL (Research Evaluating Vagal Excitation and Anatomical Links), an NIH SPARC Initiative-funded multi-site clinical study that focuses on the multi-organ effects of vagus nerve stimulation (VNS). While the application of VNS is approved for treatment-resistant depression and epilepsy, there is limited information on the multi-organ response to VNS. The REVEAL project is investigating the acute (single study visits) and chronic (12-week) effects of 6 different vagus stimulation combinations on the autonomic nervous system, cardiovascular system, metabolic system, and immune system in order to gather a more holistic view of the impact of VNS treatment.

REVEAL recently achieved a major milestone in starting to enroll participants. The first enrollment was at the University of Minnesota. Other sites in the United States that will be involved in enrollment and study activities include Stanford University, Washington University in St. Louis, the Mayo Clinic, Sheppard Pratt, Medical University of South Carolina. In Australia, a clinical site at Monash University, in Melbourne, will be led by REVEAL co-Investigator Dr. Vaughn Macefield.

The REVEAL teams aim to use these studies to generate and analyze large volumes of data on the systems-wide effects of VNS. This work will lead to a greater understanding of the physiology of the vagus nerve, potentially unlocking new possibilities for future VNS-based therapies. The successful completion of REVEAL’s clinical research aims to lay the groundwork for the development of research, technology, and therapies that will impact patients worldwide.

Research progress was presented at recent meetings held at UMN’s home field in Minneapolis Minnesota at both the SPARC Phase 2 PI Meeting and MN Neuromodulation Symposium. The de-identified data resulting from this and other REVEAL projects will be available via the SPARC Portal for researchers to access and further investigate, which opens opportunities for new discoveries and a deeper understanding of the data collected by the project.

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