NeuroPace today announced that it has received a $9.3 million National Institutes of Health grant to study Lennox-Gastaut Syndrome treatment.
The NIH — through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative — will provide up to $9.3 million over a five-year period to evaluate the use of Mountain View, Calif.-based NeuroPace’s RNS neuromodulation system to treat Lennox-Gastaut Syndrome (LGS).
“LGS is a horrific epilepsy syndrome that develops in very young children and results in daily seizures, frequent seizure emergencies and hospitalizations, and significant developmental delays,” Tracy Dixon-Salazar, executive director of the LGS Foundation, said in a news release. “Most people living with LGS have tried more than a dozen treatments and yet seizures persist and families live life waiting for the next seizure crisis. I am so encouraged by the research being done with the RNS System and am hopeful that this treatment can help LGS families who are in desperate need of better therapies.”
NeuroPace’s RNS system is a brain-responsive neuromodulation system. It has closed-loop technology that delivers personalized, data-driven treatment targeted to the seizure source by continuously monitoring brain activity, recognizing unique seizure patterns and responding in real-time with stimulation to prevent a seizure, according to the company.
The investigational device exemption study will evaluate the neuromodulation device as a therapy option, as well as for continuous monitoring and recording of brain activity to optimize LGS therapy.
Six clinical study sites will enroll 20 patients with LGS and drug-resistant generalized onset seizures. In addition, two other academic sites will create patient-specific maps of brain seizure networks for better insight into how to personalize the treatment for each participant.
“We are pleased that the NIH recognizes the promise of responsive neuromodulation to potentially address the current gap in therapeutic options for patients with debilitating seizure disorders such as LGS,” said NeuroPace chief medical officer Dr. Martha Morrell.
“These recordings obtained directly from the brain in a natural setting will show us what is happening when an LGS seizure starts and spreads,” Morrell said. “We believe that this unprecedented window to the brain will provide us with a deeper understanding of generalized onset seizure networks and help identify biomarkers in the brain that signal when a seizure is about to occur. We’re hopeful that treatment with the RNS System can ultimately improve the lives of patients with LGS and their families, and that what is learned from the brain data can also be applied to treatment of other types of generalized onset seizures.”