$21 million: Revealing the effects of vagus nerve stimulation in humans

Researchers at the University of Minnesota, Twin Cities, are leading a comprehensive global clinical study that seeks to uncover the functional effects
of vagus nerve stimulation (VNS) on the human body.

The Vagus Nerve Excitation and Anatomical Link Research Evaluation (REVEAL) project is a $21 million National Institutes of Health grant that will be conducted
over a three-year period.
REVEAL aims to study the anatomical links and functional effects of vagus nerve stimulation (VNS), an FDA-approved treatment for
epilepsy and depression.

REVEAL combines a large-scale clinical study of 144 VNS patients with three ancillary studies
.
These studies will assess the broad response
of autonomic, cardiovascular, metabolic, immune, and gastrointestinal functions to VNS parameters.
The researchers hope to generate one of the
largest publicly available datasets on human VNS function.

"The vagus nerve carries information from the brain to most organs in the body and vice versa," said
Dr.
John Osborne, professor of surgery at the University of Minnesota School of Medicine and director of the Minnesota Autonomic Modulation Alliance.
"Dysregulation of the vagus nerve underlies many pathological conditions, and we have now just discovered ways to modulate the vagus nerve to treat them
.
"

Ziad Nahas, M.
D.
, professor at the University of Minnesota School of Medicine and a psychiatrist at M Physicians, said, "VNS has a proven track record
of treating treatment-resistant epilepsy and depression.
" "The exciting aspect of REVEAL is that it will lay the foundation for
new therapeutic applications of VNS in autonomous, immune, cardiovascular and metabolic diseases.
"

During the REVEAL study, participants implanted with VNS devices will undergo extensive testing to measure physiological, molecular, imaging, genetic and neurological responses to VNS, among many other experiments and computational results
.

"A project involving so many measurement methods and physiological systems requires a large, interdisciplinary team
.
We are fortunate to have more than 40 researchers from around the world, including 30 from the University of Minnesota," said Dr.
Hubert Lim, professor of biomedical engineering in the University of Minnesota's College of Science and Engineering, a co-appointee
to the School of Medicine.

REVEAL is part of the National Institutes of Health (NIH) Stimulation of Peripheral Activities for Alleviation (SPARC) program, funded by the NIH Mutual Fund, award number 1U54AT012307, administered
by the National Center for Complementary and Integrative Health.
Those interested in participating can send inquiries to REVEAL@umn.
edu
.

The research team from the University of Minnesota includes faculty
from multiple departments in the School of Medicine, the College of Science and Engineering, and the School of Public Health.
These faculty members also represent the Center for Neural Engineering, the Institute of Medical Engineering, the Center for Quality Outcomes, Discovery, and Evaluation (C-QODE), and the Minnesota Autonomic Neuromodulation Consortium
.

In addition to Osborn, Nahas and Lim, there are three other REVEAL principal investigators: Sayeed Ikramuddin, chair of the Department of Surgery, School of Medicine; Lynn Eberly, associate dean for the School of Public Health and professor at the School of Public Health; and Vaughan Mesfield
, a professor at Monash University in Melbourne, Australia.

Partner agencies include the Mayo Clinic in Minnesota; Monash University, Australia; Stanford University School of Medicine; Washington University in St.
Louis; South Carolina Medical College; Sheppard Pratt of Maryland; and the Higher School of
Santa Ana, Italy.
Company partners include LivaNova, BRIGHT Research Partners and BIOS
.