NeuroPace Begins Feasibility Study of RNS System for Lennox-Gastaut Syndrome

The first patient with Lennox-Gastaut Syndrome (LGS) has been treated in NeuroPace Inc.’s feasibility investigational device exemption (IDE) study. The study uses the RNS System, which has demonstrated safety and effectiveness of brain-responsive stimulation for treating medically intractable focal onset seizures in people 18 and older, can also be used to treat LGS, a form of childhood onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures.

The RNS System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the U.S. Food and Drug Administration. The closed-loop technology delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing a patient’s unique seizure pattern, and responding in real-time with imperceptible stimulation to prevent seizures. By recording ongoing EEG data, the RNS System provides physicians with a unique “window to the brain,” enabling them to remotely monitor their patients, gain insights based on brain activity, and use that information to optimize patient care. Long-term clinical studies demonstrate that the RNS System provides significant reduction in seizure frequency and enduring improvements in quality of life and cognition with no stimulation-related side effects. The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance. It is currently approved in the United States as an adjunctive therapy for patients 18 years of age and older with drug-resistant focal epilepsy.
 
The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, M.D., Ph.D., the MBNA Bowman Chair in Neurosurgery and Professor and Vice Chair, Emory University Department of Neurosurgery. “An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity,” he said.
 
NeuroPace received a $9.3 million National Institutes of Health (NIH) grant through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN Initiative) to evaluate its responsive neuromodulation technology in those who suffer from LGS. Six study sites will enroll a total of 20 patients 12 years of age and older with LGS and drug-resistant generalized onset seizures.
 
“The NIH looks for ideas that could be transformative, with the potential to change how LGS is treated today,” NeuroPace Chief Medical Officer Martha Morrell, M.D., said. “In addition to finding the best detection and stimulation settings for responsive neurostimulation in LGS, we are looking to identify changes in the recorded brain data that indicate whether the therapy is effective. These so-called biomarkers may help clinicians treat LGS and also facilitate future research, including the possibility of a larger clinical study into the mechanisms of the disease and treatment approaches.”
 
Presently, antiseizure medications are the standard of care for treatment of LGS. But even with multiple medications, seizures are rarely controlled, and it is typical for people with LGS to experience increasing disability over their lifetime.
 
“Overall, treatment is rarely effective in LGS, and the outcome remains very poor,” said Tracy Dixon-Salazar, Ph.D., executive director of the LGS Foundation and mother of an adult living with LGS. “Those living with LGS need new treatment options for the many seizures, LGS-associated disorders, and treatment side-effects our loved ones suffer. The impact of LGS extends to the whole family, as we shoulder this unpredictable disease and try to manage the many physical, emotional, and financial burdens. We need better treatments now.”
 
One in 26 Americans will develop epilepsy in their lifetime, with approximately 150,000 new cases of epilepsy diagnosed annually. An estimated 3.4 million Americans currently live with epilepsy, a chronic disorder characterized by recurrent, unprovoked seizures. More people live with epilepsy than autism spectrum disorder, Parkinson’s disease, multiple sclerosis and cerebral palsy combined.ⁱ
 
Based in Mountain View, Calif., NeuroPace is a commercial-stage medical device company that developed the RNS System, the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. 

Reference 
ⁱ Epilepsy Foundation. “Facts about Seizures and Epilepsy.”