4 October 2022
£1.8 Million National Institute for Health & Care Research (NIHR) Invention for Innovation (i4i)
Challenge Award grant awarded to study how the first ever ultra-long term seizure recorder 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.

A new study launching today 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.

Epilepsy can dramatically affect a person’s day-to-day 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, which is being led by the Institute of Psychiatry, Psychology &
Neuroscience (IoPPN) at King’s College London and funded by the NIHR, 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, twenty-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. Jonas Duun-Henriksen, Director of Epilepsy Science at UNEEG medical said that the purpose of the
Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE) 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, and
Manchester.