Newswise — In February, UNC neurologist Hae Won Shin, MD, and neurosurgeon Eldad Hadar, MD, were the first in the state to implant the NeuroPace RNS System following the medical device’s recent FDA approval. In clinical trials, the NeuroPace system greatly reduced the number of seizures experienced by patients with severe epilepsy.
The device is implanted inside a patient’s skull, and works like this: a battery-powered neurostimulator is connected to two electrodes that are placed within the brain, or on the brain’s surface at the usual site or sites of a patient’s seizures. When the device, which is capable of detecting a seizure before the patient experiences any noticeable symptoms, picks up on the early signs of a seizure, it delivers an imperceptible bit of electronic stimulation, with the goal of stopping the seizure before a patient feels anything.
Shin said that this procedure is another important treatment option that she and her colleagues have to offer patients at UNC’s Comprehensive Epilepsy Center, especially patients who suffer from persistent seizures but are not eligible for traditional epilepsy surgery, when surgeons remove a portion of brain tissue from the area where seizures are originating from.
“There are a number of patients where surgery is not possible because their seizures are originating from vital areas within the brain such as cortexes controlling language, memory or movement. Or, we cannot perform surgery because the patient has more than one focus area for their seizures,” Shin said.
“The RNS system will provide lots of new opportunities for those patients because it does not require that we remove any brain tissue, and it allows us to provide therapy for patients with more than one seizure focus area.”
Shin said that she anticipates doing only a handful of these procedures a year, but for the patients who receive the device, it can produce significant results.
Clinical trials done elsewhere, prior to FDA approval, have shown that in patients who receive this therapy, 60 percent of patients will experience a 50 percent reduction in their seizures.
“We recognize that this is by no means a cure for epilepsy, but this can provide significant benefits to patients,” Shin said.
Clinical trial participants were patients who experienced three or more disabling seizures per month. At this point, the device’s effectiveness has not been evaluated in patients with less frequent seizures. The device is only approved for use in adults over age 18.
Shin said the patients she has discussed the procedure with have been excited about this new option.
“We have many patients with epilepsy who have done research and are excited about the possibility of traditional epilepsy surgery, but then go through the evaluation and find they have more than one focus area, or a focus area near a vital brain region and they are just devastated,” Shin said. “I am excited that this new device will allow us to offer therapy for those patients.”
The device can also be individualized for patients. Shin said during the initial treatment phase, physicians can monitor data collected by the device to identify common patterns in brain wave activity that may signal a seizure. The responsive nature of the NeuroPace device allows it to be programmed to recognize those patterns and deliver targeted stimulation to stop seizures before they even start.
“That’s the ultimate goal for this device. To detect a seizure very early on, to deliver targeted stimulus and stop the seizure, hopefully without the patient even feeling anything,” Shin said.
Shin said she is also excited about the NeuroPace’s data management system, which collects recordings of the patient’s brain activity from the device and stores them in a secure, web portal. Shin said she and her colleagues will be able to review this data between clinic visits to get a better sense of how the patient is doing.
“Even before seeing the patient, I can review the data to see how they are doing and if we need to make any changes to the programming of the device. It also allows me to test any potential changes to see how they might affect the patient,” Shin said.
Shin said UNC’s early adoption of this new device is a testament to the “comprehensive” nature of the UNC Comprehensive Epilepsy Center, which was again named a Level 4 epilepsy center by the National Association of Epilepsy Centers, the highest designation.
“At this point, we can provide all approved forms of treatment to our patients. I’m very proud of that.”