Brain Freeze

Freezing the Epileptic Brain

Seizures, the often frightening and historically misunderstood outward manifestations of epilepsy, have long challenged physicians and struck fear in patients. Although there are drugs on the market to control seizures, many patients receive little benefit.

But there may now be a reason to hope for some of these patients.

Though the technology is still in its infancy, a new approach to controlling seizures championed by five Duke University students - four from the Pratt School of Engineering and one from the Fuqua School of Business - may address this medical problem by harnessing the unique ability of cooling to soothe the erratic brain electrical activity causing seizures.

The students developed the business plan for the medical device in the fall of 2007 in a Pratt entrepreneurship class and have spent the past spring traveling the country entering their business plan into competitions against other start-ups. The Duke team has fared well, placing second in the University of San Francisco International Business Plan Competition in April and placing first in both the Duke Start-Up Challenge in April and the University of Maryland Business Plan Competition in May.

In the process of presenting the business plan at different competitions across the country, the students have gained invaluable input and advice from entrepreneurs and experts in the fields of venture capital and intellectual property -- the type of expertise that is essential to the success of any start-up enterprise.

The new company, which the students are in the process of incorporating as Cerene Biomedics, is the brainchild of Pratt graduate students Heidi Koschwanez, Christina Li, Carolyn Nohejl and John Stroncek, as well as Fuqua MBA student Vivek Sasikumar. The prize money they have earned so far in the competitions is being funneled into buying the materials necessary to build a prototype device.

Cerene plans to adapt technology developed for hi-tech, military and aerospace purposes and to apply it to medicine by making use of tiny micro-cooling chips - some as small as a piece of confetti -- developed by Nextreme Thermal Solutions, Research Triangle Park, N.C. Steven Rothman, M.D., director of the division of pediatric clinical neurology at the University of Minnesota, an expert in cooling as a treatment for epilepsy and father of the idea, is a member of Cerene's advisory board.

The plan is to ultimately implant these chips onto the areas of the brain where the malfunctioning "wiring" is located.  

"Once implanted, the idea is that the device will detect the aberrant nerve impulses in the brain tissue and within a millisecond, rapidly cool that area of the brain to stop the seizure," Stroncek said. "To our knowledge, this is first time anyone has taken this approach to treating epileptic seizures."

Many studies conducted in humans and animals over the past 20 years have demonstrated that cooling can stop seizures safely and effectively. Koschwanez points out that neurosurgeons operating on brains routinely use iced saline solution directly on the brain to stop seizures during surgery.

"We believe that we can create the technology that will be able to control a seizure even before it begins," Koschwanez said. "Ultimately, we are hopeful that our technology can help many patients who are in desperate need of an effective therapy. With all the great advice we've received and the contacts we've made, we feel like we have a real shot at making this happen."

Currently, about two dozen different drugs have been used to suppress seizures; however, almost one in three patients - about 900,000 Americans do not respond to the drugs. And in about one-third of those patients, the malfunctioning areas are located on the brain's surface and would be amenable to direct contact with the cooling device.

Pratt faculty member Barry Myers, who along with Melda Uzbil, leads the year-long course Invention to Application (ITA), which was where Cerene's development began. The course, which started in 2005, brings together a wide spectrum of students and faculty, including those from Pratt, Fuqua and the medical center, as well as venture capital and technology transfer experts from outside Duke.

"I firmly believe that classes like this not only give our students the real-life experience they need to truly understand what it is like to nurture an idea and bring it to life, but our faculty members also get a taste of what goes on outside the walls of academia," Myers said. "These students are starting from zero, and just like they have five to seven years to produce a thesis, entrepreneurs are also working on a similar time-frame creating their companies."

Myers, who also serves as the director of Duke's Center for Entrepreneurship and Research Commercialization (CERC), is especially impressed by all the time and work the students are putting into Cerene in addition to the research they are conducting for their degrees.  

The Cerene business plan projects that if all the benchmarks in fund-raising, animal studies and human clinical trials are met, as well as approval from the Food and Drug Administration, a product could be on the market by mid-2015.

Throughout, the Cerene team has been supported by Pratt's Department of Biomedical Engineering, Fuqua's Health Sector Management, Fuqua's Healthcare Club, Duke's CERC, Nextreme and the Harris & Harris Group.