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New Platform Helps Interpret Neuromodulation Data Into Actionable Insights for Epilepsy

Author(s):

The chief medical officer of NeuroPace discussed the newly developed nSight Platform, which allows physicians to remotely track seizure burden and activity for patients with drug-resistant focal epilepsy.

Martha Morrell, MD, chief medical officer of NeuroPace, clinical professor of neurology, Stanford University

Martha Morrell, MD

With increasing changes to how health care is provided, technology plays an even more vital role with the integrations of telehealth in the wake of the COVID-19 pandemic. To help answer this call, NeuroPace has announced a new online portal, the nSight Platform, to track seizure-related outcomes for patients with drug-resistant focal epilepsy. The platform works in tandem with the company’s RNS System, an FDA-approved neuromodulation device that delivers targeted stimulation to help prevent seizures and monitors brain activity, providing data to better inform patient care and treatment decisions for those with epilepsy. In addition, NeuroPace announced a new partnership with Seizure Tracker, a patient seizure diary app, that will allow patients to share data from the app with their physicians to better manage potential seizure triggers and trends.

Martha Morrell, MD, chief medical officer of NeuroPace, clinical professor of neurology, Stanford University, spoke with NeurologyLive on the nSight Platform and its potential to track and store patient data, opening patient-provider communication. 

NeurologyLive: What do clinicians need to know about the RNS System and the nSight platform?

Martha Morrell, MD: The RNS System is a platform technology, and the first application of the technology is for treatment of persons with medically intractable focal onset seizures. The intent of the device is to target the region from which seizures arise. Leads containing small electrodes are placed within or over the region of seizure onset using standard stereotactic techniques. Those leads are collecting data from that region directly, which is going to a neurostimulator that is placed within the skull, and that neurostimulator is sensing that data all of the time. When it is detecting patterns that are abnormal and of concern, as the physician has programmed it to do, it provides stimulation in response, and the physician also tells it how to provide stimulation. It is a closed loop—sense, detect, stimulate—but it also records all of this data, which is being acquired continuously and stored within the neurostimulator. The patient then uses a wand to transmit that to a home monitor they have, which then transmits over the internet to a portal—the patient data management system—where the physicians then have access to this data. It's amazing, this has never been seen before, this information from somebody walking around living their normal life.

However, it is also a lot of data, and the massive data can take a great deal of time to look at. It also becomes more challenging, because if you have years of data, it is really hard to see the trends unless that data is collapsed and interpreted for you. So, over the experience with RNS System, we have been able to figure out the points in that data and the information in that data that is most important for the physician to know in order to know how to manage the device, the RNS System, but also how to manage medication, dosage of medication, or whether a new medication is going to be beneficial. By looking at the data from the RNS System, there's now several publications that describe changes in 2 weeks that will let you know whether medication is going to be helpful. If you see changes in brain electrical activity, perhaps epileptiform activity increases, then you might also want to know whether the patient is complying with their medication or if there are other behavioral changes. This is all tremendously insightful. 

The nSight Platform is a major effort to take all of the information that is actionable, meaning the information that the neurologist wants to see in order to understand how to best treat their patient, and provided in a way that physicians can very quickly, very efficiently and very intuitively see all of this data processed down and collapsed into a report that requires very little effort, and will lead to changes in management of not just the RNS System, but also medications and all behavior. 

I think what I want to make sure that neurologists understand, which they already do, is that we are moving into an era of data science, we all are, in all aspects of our life. But the RNS System is an example of one of the new therapies that are acquiring great amounts of data. The challenge for us is to understand how to apply data analytics, so that we have information that we can comprehend, that we can condense, and that we can act upon.

What benefit does the platform potentially provide for patients and providers?

This is the very first time, of course, that physicians have had access to this type of quantitative brain data in individuals who are walking about living their normal lives. We've really relied on patients being able to tell us how they are doing, and that's difficult. It's difficult for a patient to be able to relay with 100% accuracy, how they're doing minute by minute, but for somebody with seizures, [it is difficult] to know how many times a seizure has occurred. Would I know if I had a seizure while I was asleep? Probably not. The nSight platform shows what has occurred according to times of day, and days over the week, and weeks over the month. 

I could, for example, see my patient in March, and I perhaps have started them on a new medication. When that patient comes back 2 or 3 months later, I will actually hear from them how they are doing, which is critically important. In addition, looking at the nSight platform, I'll be able to see, according to the trends that are shown, what has been going on with brain electrical activity as well. This will be an important additional source of information for me in assessing whether I'm on the right track with that particular medication, or with that dose of medication. That's one example. Another example might be, and this is one from one of one of my patients who is a new mother. I can tell based on the data from the insight report, which is showing me how active her epileptiform activity is, which is the activity I want to suppress. I can see how active that is according to certain times of day, and I can tell when I needed to counsel her to have her husband step in and do a little more of that nighttime work, so it's a whole window on what is going on with a patient that is very informative.

What type of data is this providing and what are the advantages of this process over typical patient monitoring? 

There are 2 sources of data; the primary source is a platform called the Patient Data Management System. The way the RNS System works, is that information is stored within the neurostimulator that is located within the skull, and that is transmitted wirelessly to a patient's remote monitor. From there, it is sent to the patient data management system over the internet, which is a library that stores all of the information on each patient that has come from RNS System, but the information is being collected 24 hours a day. So, there’s 24 hours, 7 days a week data on how often a detection of abnormal activity has occurred, where that detection has come from, and what the device has done. In addition, there's samples of the actual intracranial EEG, which is like the EEG that neurologists have been looking at their entire careers. But you can imagine that if you had hours and hours and hours, it just really is daunting, and so it becomes less valuable because it is too hard to absorb and process, especially when you're treating a patient over months or years. To have this platform that provides a way to synthesize and integrate this data so that you can see what's important and trends over time, it helps you understand the cadence of your patient's disease and the impact of interventions, whether that be the RNS System, or as we just discussed, medications or changes in behavior.

The specific information provided in the nSight platform includes the numbers of electrographic seizures that the patient has had and the circadian cycles of epileptiform activity—you can look and see how active the epileptic form activity is, at certain periods of the day. The physician can also look at how the device was programmed, specifically how it was programmed to detect abnormal activity and how it was stimulated, and it compares that to ways that the patient has been programmed in the past so that it becomes easy to understand where the next best place would be to go. 

In addition, the physician can look and see, within a practice, how all the physicians are doing as a group, because we work with our colleagues, but we don't necessarily know what the experience of our colleagues is. So, it's very helpful to see within a group, what types of patients are being treated with the RNS System and how they are doing.

Transcript edited for clarity.

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