Developed by a team of specialists at University of Cincinnati’s (UC) College of Medicine, the non–invasive headgear device that uses radio waves to detect changes in the brain is drawing both attention and investment.

In 2008, Matthew Flaherty, MD, and Opeolu Adeoye, MD, both faculty members at the UC College of Medicine and physician researchers at the UC Gardner Neuroscience Institute, identified a clinical need to evaluate the brain activity for patients who are in the hospital, often sedated and sometimes on a ventilator. "This is a scenario I’ve seen as a neurologist, where we evaluate in an ICU, and we don’t know what’s going on with patient brains,” says Flaherty. "Maybe three or four days could pass with the patient in a sedated state, and during that time there could be neurological damage.”

With this challenge in mind, these UC physicians posed the question: "Is there a way other than sending people down for repeated CT scans to keep track of what’s going on in the brain?” This led to the idea of a non–invasive central nervous system sensor, using radio frequency waves similar to cell phone technology. Flaherty and Adeoye along with two other UC researchers – George ‘Chip’ Shaw, MD, PhD, and Joe Clark, PhD – applied for and received a small grant for exploring point–of–care devices for neurotechnologies (POC–CENT), through the NIH. "It allowed us to do some proof of principle testing – we chose intracerebral hemorrhage as the disease state – we create a model for it, and we felt there was a reasonable chance we could see blood in the head,” explains Flaherty.

The device would monitor and provide real–time data of changes in the brain, including swelling and hemorrhage, so that doctors can deliver more precise treatment. The goal is to reduce deaths and long–term disabilities that result from hemorrhagic stroke or traumatic brain injury. In addition, the technology may be developed to address other brain conditions, such as ischemic stroke, seizure and hydrocephalus, and modified to fit into care settings outside of the hospital.

To develop a prototype for the device, Flaherty and Adeoye enlisted the help of co–inventor Shaw, associate professor of emergency medicine, with a strong physics background.

Shaw built the first device at UC "and he was probably the most important in the process early on,” says Flaherty. They also partnered with Ken Wagner, PhD, (then a research scientist at the VA), Joseph Korfhagen, PhD, then a graduate student, and Joe Clark, PhD, a professor in the Department of Neurology and Rehabilitation Medicine, to help coordinate animal model device testing. Korfhagen stayed on with Sense and is now the company’s director of research and development.

The next big step forward for the team was a grant from UC’s Technology Accelerator for Commercialization in 2013.

In the fall of 2014, the team received an Ohio Third Frontier grant and soon thereafter a Phase I Small Business Innovation Research (SBIR) award from the National Science Foundation (NSF), which led them to a Phase II, NSF–SBIR award in 2016.

The device has been refined along the way since that first model as well, from one pair of antenna to a multiple antenna array, and the Sense team has a functioning prototype and has been approved to begin its first in human clinical trial in patients with ICH at UC Medical Center.