Ludwig improving neuromodulation safety testing through BRAIN Initiative grant

As neuromodulation therapies for treating a growing number of conditions proliferate and advance, they’ve rapidly outpaced knowledge and methods for proactively understanding the safety of electrical stimulation of the nervous system.

But those kind of underlying insights could accelerate development—and U.S. Food and Drug Administration approval—of therapies.

With that in mind, University of Wisconsin-Madison Biomedical Engineering Associate Professor Kip Ludwig is leading a five-year, $1.8 million project to create a new benchtop testing framework to predict safety issues concerning a wide range of electrodes. The funding is part of the National Institutes of Health’s (NIH) Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which then-President Barack Obama launched in 2013.

James Trevathan, a research scientist in Ludwig’s lab in the Wisconsin Institute for Translational Neuroengineering (WITNe) at UW-Madison, is a co-investigator on the grant, which is among a slew of projects for which Ludwig’s lab has received funding in recent months.

He’s part of a collaboration led by Case Western Reserve University and Duke University that landed a $15.75 million contract from NIH to map the human vagus nerve—a key pathway for many neuromodulation treatments—in unprecedented detail. The project is part of NIH’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program, which Ludwig helped launch during his time as the program director for neural engineering at the federal agency.

Ludwig, who is the neuroengineering lead for the Grainger Institute for Engineering and co-director of WITNe, is also leading a $2.5 million NIH project to optimize a class of neuromodulation therapies called baroreflex activation therapy. And he’s serving as a co-investigator on a Duke-led NIH grant to develop new waveforms for blocking nerve activity, which could have implications for treating hypertension, heart failure and cardiac arrythmias.

Ludwig’s group is also working with industry partners Abbott Laboratories and the Alfred Mann Foundation to better understand the neuroanatomy to inform electrode design and improve therapeutic effects while minimizing side effects.

Lastly, through a Wisconsin Alumni Research Foundation Accelerator award, Ludwig’s lab is conducting further testing of a noninvasive stimulation strategy of a cranial nerve to encourage blood flow and the clearance of metabolic waste products. The therapy could represent a preventative treatment for neurodegenerative diseases such as Alzheimer’s and Parkinson’s.