NeuroPace, a California-based medical technology company, has developed the RNS system, an implantable neuromodulation device for drug-resistant focal epilepsy. The system continuously monitors brain activity and then responds appropriately to the source of seizures 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 doctor, allowing them to track progress. In a new development, NeuroPace has received $ 9.3 million 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 disease is genetic and is characterized by generalized seizures and progressive cognitive dysfunction.
Pending FDA approval, NeuroPace will conduct a feasibility research device exemption study, which will mark the first evaluation of this neuromodulation device in Lennox-Gastaut syndrome. Interestingly, hopefully, the study will shed light on the condition itself, such as identifying the source of seizures in the brain, as the device provides continuous monitoring of brain activity.
Watch a video about the RNS system below.
Medgadget He had the opportunity to speak with Martha Morrell, medical director of NeuroPace, about the technology and research proposal.
Conn Hastings, Medgadget: 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 childhood genetic onset epilepsy that causes cognitive dysfunction and frequent generalized seizures that often cause injury.
Patients living with LGS frequently experience seizure emergencies, hospitalizations, and developmental delays. Many patients have struggled to find appropriate treatments to prevent or stop ongoing seizures.
Medgadget: What treatments are currently available for the disease? Do they work well?
Martha Morrell: Current treatments for LGS are antiepileptic drugs. Unfortunately, antiepileptic drugs are not effective in controlling seizures in a large portion of the LGS population, and many patients are treated with multiple medications and have to live with side effects that are difficult to tolerate. In addition, these patients often struggle with various life-threatening challenges, such as psychological dysfunction, social stigma, reduced quality of life, and increased risk of death from unexpected sudden death in epilepsy.
Medgadget: Please give us an overview of the NeuroPace RNS system.
Martha Morrell: The RNS system is the only commercially available closed-loop neuromodulation system that helps prevent seizures at its source. The implantable brain device, which includes an implantable neurostimulator located under the scalp, continuously monitors brain activity and recognizes the patient’s unique seizure patterns. The RNS system 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 allows them to make treatment decisions. more informed and personalized.
Medgadget: How effective is the system at preventing epileptic seizures? How long can you stay in place before removing / replacing it?
Martha Morrell: We have long-term clinical data in adults with drug-resistant focal seizures that demonstrate continuous improvement in outcomes over time. After three years or more, patients in a real-world study experienced an unprecedented average reduction of 82% in seizure frequency, the largest published seizure reduction for any neuromodulation study for epilepsy. focal. mean stimulation 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. RNS 320 is the latest neurostimulator and is expected to last an average of 8 years under normal use. More than 90% of patients choose to replace the device when the battery runs out.
Medgadget: Please tell us about the next study of the RNS system in Lennox-Gastaut syndrome.
Martha Morrell: The RNS system will be used to treat generalized seizures in patients with LGS. This is the first time neuromodulation has been evaluated in patients with this type of epilepsy. An additional goal is to find out if LGS seizures start in the cortex of the brain or if they come from deep nuclei of the brain (the thalamus). It is currently unknown, and it is very important to understand where to target treatment for these patients and how to intervene in the focus of seizures and on the routes of seizure 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 the patient’s response and report changes in stimulation parameters.
Medgadget: Assuming positive results for the RNS system in Lennox-Gastaut syndrome, what difference could treatment make in the lives of people with Lennox-Gastaut syndrome and their families?
Martha Morrell: Most patients living with LGS have tried more than a dozen medications, and yet the seizures persist. If we can show that sensitive neuromodulation helps patients with LGS, there will be a completely new treatment option for them. Better seizure control could reduce or even stop the progressive cognitive impairment associated with LGS and could reduce the risk of seizure-related death and injury. If the RNS system is effective, the quality of life of LGS patients and their families can be greatly improved.
Medgadget: Where do you see neuromodulation in the future? Do you have any plans for new technologies?
Martha Morrell: The brain-sensitive platform of the RNS system offers a personalized and real-time treatment to the source of seizures. This platform can drive a better level of care for patients with 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.
Link: NeuroPace Company Home …
Flashbacks: NeuroPace epileptic seizure control system: interview with Dra. Martha Morrell, CMO of NeuroPace; NeuroPace: perhaps first since Jesus to prevent and treat epilepsy; NeuroPace is seeking FDA approval for its RNS system; NeuroPace obtains FDA pre-market approval for the RNS stimulator; NeuroPace RNS System for Epilepsy Gets FDA Approval for MRI Labeling; Neuropace implantable epilepsy device showing positive signs in the initial clinical study;