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NeuroPace Awarded Five-Year NIH Grant Funding of More than $9M to Study RNS System in Patients with Lennox-Gastaut Syndrome
Feasibility IDE study will be the first to evaluate responsive neuromodulation for a severe and disabling childhood-onset epilepsy MOUNTAIN VIEW, Calif., June
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[{"type":"text","content":"Feasibility IDE study will be the first to evaluate responsive neuromodulation for a severe and disabling childhood-onset epilepsy MOUNTAIN VIEW, Calif., June 30, 2021 (GLOBE NEWSWIRE) -- NeuroPace, Inc., a medical technology company dedicated to transforming the lives of people suffering from epilepsy, today announced that it has received a National Institutes of Health (NIH) grant through the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative that will provide up to $9.3 million over five years to evaluate the use of NeuroPace’s RNS® System to treat Lennox-Gastaut Syndrome (LGS). LGS is a devastating form of childhood-onset epilepsy that causes cognitive dysfunction and frequent generalized onset seizures that often lead to injury. The Investigational Device Exemption (IDE) study, which will be the first to evaluate a neuromodulation device in patients with Lennox-Gastaut Syndrome, is projected to start enrolling patients in the second half of next year. \"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,\" said Tracy Dixon-Salazar, Ph.D., Executive Director of the LGS Foundation and mother of an adult living with LGS. \"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.\" The study funded by the grant will explore the potential of NeuroPace’s brain-responsive neuromodulation technology as a new therapy for persons living with LGS. In addition to the potential therapeutic benefits, the ability of the RNS System to provide continuous monitoring and recording of brain activity could help to optimize therapy for each individual, and may offer new insights into this condition. The NIH-funded research will be a collaborative effort involving eight U.S. academic centers. Six clinical study sites will enroll a total of 20 patients with LGS and drug-resistant generalized onset seizures. Two other academic sites will create patient-specific maps of brain seizure networks, providing unprecedented in...