A new study will use revolutionary long term seizure tracking technology to monitor and potentially predict patterns in epileptic seizures using continuous, reliable, and objective data collection of brain activity in people with drug-resistant epilepsy.
A £1.8M National Institute for Health & Care Research (NIHR) Invention for Innovation (i4i) Challenge Award grant will support work on the first ever ultra-long term seizure recorder, which could help improve outcomes and reduce significant risk of harm for the 33% of patients with epilepsy whose condition cannot presently be controlled with medication.
The Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE) trial, which is being led by the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and will also involve patients at Salford Royal, hopes to establish if the use of a small implant that records brain activity can improve outcomes for treatment and care.
While seizures can occur in predictable patterns, it is difficult to accurately track how often seizures occur as it relies on the person affected manually documenting their attacks in a diary. As seizures can have an amnesic effect, and can happen while a person is asleep, accurately recording these events is often not possible.
Subcutaneous implanted EEG is a new technology. Conventional EEG technology either requires the person to be admitted to hospital or be tested at home, using EEG electrodes glued to their scalp, which can be undertaken for only a few days. NHS waiting lists for these tests can vary from months to years.
Subcutaneous implanted EEG, the technology being trialled in this study, enables researchers to continuously record EEG in an unobtrusive way, for up to 15 months, while the person lives their life completely normally.
The trial will recruit 33 people with drug resistant epilepsy and implant a miniaturised electroencephalogram (EEG) device just under their scalp during a minimally invasive, 20 minute procedure that is performed under local anaesthetic. Researchers will then monitor each person’s brainwaves over six months.
By tracking the brainwaves, researchers can accurately count the person’s seizures, which enables them to provide reliable information to clinicians, as an
alternative to unreliable seizure diaries.
The study’s Principal Investigator, Professor Mark Richardson, Head of the School of Neuroscience and Paul Getty III Professor of Epilepsy at King’s IoPPN said: “This technology is a game-changer for epilepsy therapy as it enables us to detect and count a person’s seizures with accuracy. Clinicians treating people with epilepsy frequently make changes to therapy in the hope of improving the lives of the third of people whose seizures have not yet responded to treatment. We don’t know whether a change in treatment has been helpful without a very accurate count of seizures. Unfortunately, seizure diaries are often not accurate enough to judge whether treatment has led to any improvement.
“What the use of ultra long-term EEG opens up, is the possibility, in future, of very accurately judging the effect of a change in treatment. We also anticipate that ultra long-term EEG will allow us to quickly identify that someone’s epilepsy is deteriorating so that we can immediately step-up their care. This has the potential to be truly revolutionary for people living with a difficult illness.”
Dr Rajiv Mohanraj is a Consultant Neurologist at the Manchester Centre for Clinical Neurosciences at Salford Royal (part of Northern Care Alliance NHS Foundation Trust), which will take part in the study.
He said: “Ultra long-term monitoring of EEG promises to reveal insights into epilepsy and open up avenues for new types of therapeutic intervention to benefit people with epilepsy. Improving the information we have about people’s seizures is an important first step towards more effective treatments and interventions.
“We are excited to be working with Prof Richardson and colleagues on this research to understand the clinical utility of this innovative new technique.
“This is a very significant study which brings hope to those with drug-resistant epilepsy and their families.”
Dr Jonas Duun-Henriksen, Director of Epilepsy Science at the Danish company that developed the ultra long-term EEG solution, UNEEG medical, said that the purpose of the trial is to examine what are the costs of introducing subcutaneous EEG into the current NHS workflow, and what are the advantages.
“Our unique device is the first technology to reach the market allowing ultra long-term EEG recording. It speaks directly to the NHS goals of improving patient outcomes via patient-friendly, at home, data collection and evidence-based, individualised, patient-focused medicine. Our goal is to provide clear evidence of device accuracy and acceptability for patients and professionals, and health economics modelling of the impact on the NHS. If clinicians are measuring outcomes better, seizure control is reached for more people, and clinicians can detect disease deterioration to avoid people being admitted to hospital.
“At the end of the study, we hope to have information that we can then take to the National Institute for Health & Care Excellence (NICE) and commissioners, to demonstrate that it should be routinely funded.”
Alison Fuller, Director of Health Improvement and Influencing at Epilepsy Action, said: “This is a really promising and exciting departure from traditional seizure monitoring methods towards helping people with epilepsy to better understand, and therefore manage, their seizures. Seizure diaries only offer a snapshot of true activity, while continuous monitoring could identify more subtle patterns and provide a much more accurate picture of what is happening.
“This new technology also has the advantage of overcoming some of the limitations or disruption people experience with more conventional EEGs. These often require extended hospital stays or the need for sleep deprivation, which can have a knock-on negative impact on seizures.
“Having better evidence and knowledge will undoubtedly improve outcomes in safety and quality of care, which could ultimately help to reduce epilepsy-related deaths. Epilepsy Action is proud to be supporting the study and we look forward to watching how it changes the landscape in current treatment methods for people with epilepsy.”
The study will take place in London with support from NHS trial centres in Newcastle, Cardiff, as well as Salford.