NeuroPace Feasibility Study of Its RNS System for Lennox-Gastaut Syndrome Now Underway
NeuroPace, Inc. (Nasdaq: NPCE), a commercial-stage medical device company focused on transforming the lives of people living with epilepsy, today announced that the first patient with Lennox-Gastaut Syndrome (LGS) was treated in its feasibility investigational device exemption (IDE) study. LGS is a devastating form of childhood onset epilepsy characterized by cognitive dysfunction and frequent generalized onset seizures that often lead to injury. 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, to test whether brain-responsive neurostimulation can also be used to treat LGS.
The first procedure took place at Emory Healthcare in Atlanta and was performed by Robert E. Gross, MD, PhD, 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.”
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,” said Martha Morrell, MD, Chief Medical Officer of NeuroPace. “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. However, 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, PhD, 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."