EEC 2022 | Ultra-long-term subcutaneous EEG monitoring of epileptic seizures

So today you have a routine EEG or a telemetry, or even a [inaudible 00:00:13] in the hospital, where the patients are monitored for 30 minutes, or up to two weeks sometimes. But it’s all in hospital, which is really good for diagnostic issues. But when it comes to monitoring over a longer term and understanding how the seizure burden progressed, all we have is a diary. And unfortunately we know that the patients aren’t that good at reporting. Often they report 25 to 50% of their seizures, and that makes it very difficult to optimize the anti-seizure medication.

So what we’ve developed is this subcutaneous, ultra-long-term EEG monitor, that records the brain waves continuously and thereby objectively tells you how many seizures does the patient have. And thereby you can see a direct measure, whether the changes in medication have an effect or not.

We started our first epilepsy trial in Denmark five years ago. We are now conducting trials in the UK, in the Netherlands. We have a study in the US, and in Germany as well, as well as other places. So we are trying to use it in a lot of different countries and a lot of different settings. However, the issues are very similar, especially if the patients have only few seizures. So infrequent seizures where it’s difficult to record them, in the hospital setting as before, or when the patients are known to be really not that adherent to their diary. So we are trying right now to show the direct value, how you can treat your patients better and provide a better outcome for these people.

Based on the first Danish trial, where we had nine people with epilepsy participating, they wore our device for three months while they also kept a diary on the side. We saw a wide range of different expressions when it came to how they used the diary. So we had two patients who had approximately 20 seizures, both, and they reported no seizures at all in their diary. So thereby, it’s just evident that you can’t treat based on the diary, and thereby the 20 seizures gives you a much better understanding of how is the burden for them.

Then we have some patients who seem to be heavily overreporting. So that could be anything like, “I woke up, I’m feeling tired. Did I have a seizure tonight?” They questioned it, but still put it down in the diary. And then we could go through the night and see, “Oh, you didn’t have a seizure,” or “You did have a seizure.” So both, in kind of empowering the patient, letting them understand what symptoms are correlated with an EEG signature of a seizure, and which are merely normal expressions that doesn’t have anything to do with your seizures.

And then we also have some patients where we saw that they were really good at reporting their seizures. So you could say that we didn’t really add anything except that we now knew that we could trust their diaries. And when they actually reported it, we could directly see, okay, there are the changes that they find themselves. And then we had one patient where we didn’t find any seizures during the recording period. And obviously, that makes it difficult to say, okay, it’s just because it’s even more infrequent, or doesn’t the patient have seizures, that’s difficult to say. So those results I’ll be talking about at the conference, and showing a little bit more how we can clinically use it in the everyday management of people with epilepsy.

So today, we merely count the number of seizures, but I believe that measuring the EEG continuously will provide you a much more wholistic understanding of how is that person actually doing. So we are looking into, if we can provide some sleep measures for the clinicians. We are looking into IEDs, interictal epileptiform discharges, how they might vary over time, do they also change based on your medicine changes. That might make it easier or faster to treat your patient if you can use the IEDs as a proxy of the number of seizures, or as a proxy of your seizure burden. We are looking into just understanding how long are the seizures, can we do anything based on that? And a lot of other things that provide a much more, I call it a wholistic view of how the patient is doing, and how we should treat them in the future.