Study of using tracking technology to predict seizure patterns

A new study will use long-term seizure tracking technology to monitor and potentially predict epileptic seizure trends using continuous collection of brain activity data in people with drug-resistant epilepsy.

Epilepsy can significantly affect a person’s daily life and a third of people with epilepsy cannot be managed with medication. The Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE) trial, led by the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and funded by the NIHR, hopes to establish whether the l he use of a small implant that records brain activity can improve treatment and care outcomes.

Although seizures can occur in predictable patterns, it is difficult to accurately track seizure frequency, as it depends on the affected individual manually documenting their attacks in a diary. As seizures can have an amnesic effect and can occur while a person is sleeping, it is often impossible to accurately record these events.

Subcutaneously implanted EEG is a new technology. Conventional EEG technology either requires the person to be admitted to hospital or to be tested at home, using EEG electrodes taped to their scalp, which can only be done for a few days. NHS waiting lists for these tests can range from months to years. Subcutaneously implanted EEG, the technology being tested in this study, allows researchers to continuously record the EEG inconspicuously for up to 15 months while the person is living a completely normal life.

The trial will enroll 33 people with drug-resistant epilepsy and implant a miniaturized electroencephalogram (EEG) machine just under their scalp in a twenty-minute minimally invasive procedure performed under local anesthesia. The researchers will then monitor each person’s brain waves for six months. By tracking brain waves, researchers can count the person’s seizures, allowing them to provide reliable information to clinicians, as an alternative to seizure diaries.

The study’s lead researcher, Professor Mark Richardson, Director of the School of Neuroscience and Paul Getty III Professor of Epilepsy at King’s IoPPN, said: “This technology is a game-changer for the treatment of epilepsy because it allows us to detect and count a person’s seizures accurately. Clinicians who treat people with epilepsy frequently change treatment in hopes of improving the lives of the third of people whose seizures have not yet responded to treatment. We don’t know if a change in treatment was helpful without a very accurate seizure count. Unfortunately, seizure diaries are often not accurate enough to judge whether treatment has resulted in an improvement.

“What the use of the very long-term EEG opens up is the possibility, in the future, of judging very precisely the effect of a change in treatment. We also anticipate that the very long-term EEG will allow us to quickly identify that a person’s epilepsy is deteriorating so that we can immediately intensify their care. This has the potential to be truly revolutionary for people living with a difficult disease.

Dr. Jonas Duun-Henriksen, director of Epilepsy Science at the Danish company that developed the ultra-long-term EEG solution, UNEEG medical, said the purpose of the Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG trial ( REAL-ASE) is to examine what are the costs of introducing subcutaneous EEG into the current NHS workflow, and what are the benefits.

“Our unique device is the first technology to hit the market allowing very long-term EEG recording. It speaks directly to the NHS goals of improving patient outcomes through user-friendly, home-based data collection and evidence-based, individualized, patient-centred medicine. Our aim is to provide clear evidence of the accuracy and acceptability of the devices for patients and professionals, together with health economic modeling of the impact on the NHS. If clinicians measure outcomes better, seizure control is achieved for more people and clinicians can detect worsening disease to prevent people from being hospitalized.

“At the end of the study, we hope to have information that we can then pass on to the National Institute for Health & Care Excellence (NICE) and the commissioners, in order to demonstrate that it should be systematically funded.”

Alison Fuller, Director of Health and Influence Improvement at Epilepsy Action, added, “This is a really promising and exciting departure from traditional methods of monitoring seizures to help people with epilepsy to better understand, and therefore manage, their seizures. Seizure logs only offer a snapshot of actual activity, while continuous monitoring could identify more subtle patterns and provide a much more accurate picture of what’s going on.

“This new technology also has the benefit of overcoming some of the limitations or disruptions that people experience with more conventional EEGs. These often require extended hospital stays or the need for sleep deprivation, which can negatively impact seizures.

“Having better evidence and knowledge will undoubtedly improve safety and quality of care outcomes, which could ultimately help reduce epilepsy-related deaths. Epilepsy Action is proud to support the study and we look forward to seeing how it will change the landscape of current treatment methods for people with epilepsy.

The study will take place in London with support from NHS trial centers in Newcastle, Cardiff and Manchester.

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