By Alison Trinidad
On Dec. 18, 2013, Keck Medicine of USC became the world’s first medical center to surgically implant a responsive brain device newly approved by the U.S. Food and Drug Administration (FDA) to treat epilepsy, with the potential to help millions of people worldwide.
The device, manufactured by NeuroPace Inc., detects and then directly responds to abnormal brain activity to prevent seizures before they occur. In a three-hour surgery, USC faculty physicians implanted the device in a 28-year-old Lakewood, Calif., woman who was diagnosed with epilepsy in 2004.
Kathleen Rivas, an aspiring journalist who sought care from the university’s student health center in 2009 while earning her master’s degree elected to have the implant because medication had not fully controlled her seizures. Over the next few months, her doctors will program the device to detect specific brain activity indicative of a seizure’s onset.
“I’m just so lucky to be here at USC,” said Rivas. “Without faith and trust in my neurologist and neurosurgeon, I don’t know where I’d be. My life is in their hands.”
Epilepsy affects approximately 65 million people worldwide, including nearly 3 million in the United States. Those who can tolerate medication and whose seizures are completely controlled usually lead a normal life, but the disease can be devastating for the up to 40 percent who experience uncontrolled seizures.
The device is the world’s only responsive neurostimulation (RNS) system approved for clinical use. USC physicians have been studying the technology since 2006 and are among the first authorized to prescribe its use since FDA approval on Nov. 14, 2013.
“This has the potential to be a game-changer for patients with epilepsy,” said Christianne Heck, MD, MMM, associate professor of neurology at the Keck School of Medicine of USC, medical director of the USC Comprehensive Epilepsy Program and principal investigator of the device’s clinical study at USC. “Unlike other neurostimulators on the market, this system looks for just the right circumstances to stop a person’s seizure from happening.”
Most people with epilepsy gain complete or partial control of their seizures through medicine or surgery. USC’s surgical epilepsy program has had an 80 percent cure rate among patients who do not respond to anti-seizure medications. RNS may help the remaining 20 percent.
“We have become very good at surgically removing the areas of the brain where these seizures start, but we have limited options when a person’s seizures begin in critical zones, such as those that affect speech or movement,” said Charles Liu, MD, PhD, professor of neurosurgery and neurology at the Keck School, surgical director of the USC Comprehensive Epilepsy Program and co-director of the new USC Center for Neurorestoration with Heck. “Devices like this provide an option for patients who live with uncontrollable seizures because no available treatment works for them.”
FDA approval of the RNS device came after a randomized clinical trial of 191 patients with drug-resistant epilepsy across 32 clinical sites. The study showed that, by three months after the device was turned on, patients experienced a nearly 38 percent reduction in monthly seizures, compared to a roughly 17 percent reduction among patients who had the implant turned off. Two years post implant, 55 percent of patients experienced a 50 percent or greater reduction in seizures.
“Academic medical centers are centers of innovation and education that directly contribute to the medical breakthroughs that continue to redefine health care,” remarked Tom Jackiewicz, MPH, senior vice president and CEO of USC Health. “Drs. Liu and Heck are blazing a trail in neurological research and care that ultimately will change people’s lives for the better. Keck Medicine of USC is proud to serve as a keystone for their efforts.”