NeuroPace, a medtech company based in California, has developed the RNS system, an implantable neuromodulation device for focal drug-resistant epilepsy. The system continuously monitors brain activity and then responds appropriately to target the seizure source in the brain for personalized seizure prevention. The company reports that the stimulation provided by the device is imperceptible to patients.
The implant can share the EEG data it collects with each patient’s physician, allowing them to track progress. In a new development, NeuroPace has received $9.3M from the NIH to study the RNS system in the treatment of Lennox-Gastaut Syndrome, a severe form of epilepsy that begins in childhood. The condition is genetic and is characterized by generalized onset seizures and progressive cognitive dysfunction.
Pending FDA approval, NeuroPace will undertake a feasibility investigational device exemption study, which will mark the first assessment of such a neuromodulation device in Lennox-Gastaut Syndrome. Interestingly, the study will hopefully cast light on the condition itself, such as identifying the source of the seizures in the brain, as the device provides continuous monitoring of brain activity.
See a video about the RNS system below.
Medgadget had the opportunity to speak with Martha Morrell, Chief Medical Officer at NeuroPace, about the technology and proposed investigation.
Conn Hastings, Medgadget: Please give us an overview of Lennox-Gastaut Syndrome and how it affects patients.
Martha Morrell, NeuroPace: Lennox-Gastaut Syndrome (LGS) is a severe form of genetic childhood-onset epilepsy that causes cognitive dysfunction and frequent generalized onset seizures that often lead to injury.
Patients living with LGS frequently experience seizure emergencies, hospitalizations and developmental delays. Many patients have struggled to find adequate treatments to prevent or stop the continuous seizures.
Medgadget: What treatments are currently available for the condition? Do they work well?
Martha Morrell: Current treatments for LGS are anti-epileptic drugs. Unfortunately, anti-epileptic drugs are not effective at controlling seizures in a large portion of the LGS population, and many patients are treated with multiple drugs and must live with difficult to tolerate side effects. Additionally, these patients often struggle with a variety of life-impacting challenges including psychological dysfunction, social stigmatization, reduced quality of life, and increased risk of mortality from Sudden Unexpected Death in Epilepsy.
Medgadget: Please give us an overview of the RNS System from NeuroPace.
Martha Morrell: The RNS System is the only commercially available closed-loop neuromodulation system that helps prevent seizures at their source. The implantable brain device, which includes an implantable neurostimulator placed under the scalp, continuously monitors brain activity and recognizes a patient’s unique seizure patterns. The RNS System then responds in real-time with personalized therapy to prevent seizures. The patient does not perceive the stimulation, and the device is not visible to others. By recording ongoing intracranial EEG data and making it available through a secure online portal, the RNS System provides physicians with unprecedented visibility into their patients’ long-term seizure patterns and enables them to make more informed, personalized treatment decisions.
Medgadget: How effective is the system at preventing epileptic seizures? How long can it remain in place before removal/replacement?
Martha Morrell: We have long-term clinical data in adults with drug-resistant focal seizures that demonstrates continuous improvement in outcomes over time. At three or more years, patients in a real world study experienced an unprecedented 82% median reduction in seizure frequency—the greatest seizure reductions published for any neuromodulation study for focal epilepsy.Our approach is proven to provide exceptional clinical outcomes through approximately three minutes of stimulation on average per day (vs. hours of open-loop stimulation per day). Unlike other stimulation therapies, such as vagus nerve stimulation and deep brain stimulation, there are no chronic side effects associated with the RNS System. The RNS 320 is the newest neurostimulator and is anticipated to last an average of 8 years under typical use. More than 90% of patients choose to replace their device when their battery is depleted.
Medgadget: Please tell us about the upcoming study of the RNS System in Lennox-Gastaut Syndrome.
Martha Morrell: The RNS System will be used to treat generalized onset seizures in LGS patients. This is the first time that neuromodulation will ever be evaluated in patients with this type of epilepsy. An additional aim is to seek to establish whether LGS seizures begin in the cortex of the brain or whether they come from deep nuclei in the brain (the thalamus). This is not currently known, and it is very important in order to understand where to target treatment for these patients and how to intervene at the seizure focus and over the pathways by which the seizures spread. We will use brain data collected by the RNS System to look for electrical biomarkers in the brain that can be used to assess how the patient is responding and inform changes in stimulation settings.
Medgadget: Assuming positive results for the RNS System in Lennox-Gastaut Syndrome, what difference could the treatment make in the lives of those with Lennox-Gastaut Syndrome and their families?
Martha Morrell: Most patients living with LGS have tried more than a dozen medications and yet seizures persist. If we can show that responsive neuromodulation helps LGS patients, there will be an entirely new treatment option for them. Better control of seizures could reduce or even halt the progressive cognitive deterioration associated with LGS, and could reduce the risk for seizure related death and injury. If the RNS System is effective, quality of life may be greatly improved for patients with LGS and their families.
Medgadget: Where do you see neuromodulation going in the future? Have you any plans for new technologies?
Martha Morrell: The RNS System’s brain-responsive platform delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients suffering from drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.
Flashbacks: NeuroPace Epileptic Seizure Control System: Interview with Dr. Martha Morrell, CMO of NeuroPace; NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy; NeuroPace Seeks FDA Approval for Its RNS System; NeuroPace Gets FDA Pre-Market Approval for RNS Stimulator; NeuroPace RNS System for Epilepsy Gets FDA Approval for MRI Labeling; Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study;