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REAL-ASE trial

Scientists secure funding to study how technology can improve epilepsy

Published on: 4 October 2022

A new study will use revolutionary seizure tracking technology to monitor and potentially predict patterns in epileptic seizures using brain activity data in those with drug-resistant epilepsy.

Epilepsy can dramatically affect a person’s day-to-day life and for a third of people with the condition cannot be managed with medication.

Scientists at Newcastle University are part of a £1.8m Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE) trial, led at King’s College London and funded by the National Institute for Health and Care Research.

The trial hopes to establish if the use of a small implant that records brain activity can improve outcomes for treatment and care for patients with epilepsy.

Urgent need

Dr Rhys Thomas, Clinical Senior Lecturer at Newcastle University and Honorary Consultant in Epilepsy at Newcastle upon Tyne Hospitals NHS Foundation Trust said: “There is an urgent unmet need for interventions that reduce all epilepsy risks, including sudden death in epilepsy.

“This is particularly true for people who carry a higher risk, including those with a learning disability, who live alone, and pregnant women.

“The REAL-ASE study aims to accurately monitor the number and pattern of seizures because currently we simply don’t know how often most people have their seizures.

“Our study is a real opportunity to meet the need for community monitoring of seizures for at-risk groups: patients with frequent convulsive seizures, particularly in sleep. There may also be many people who don’t know when they are having these critical events.

“We hope that ultra-long-term electroencephalogram (EEG) monitoring being assessed in this study could be a method of rapidly alerting a clinical team to a change in the nature of the patient’s seizures which are out of character for them.”

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.

Conventional EEG technology 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.

However, subcutaneous implanted EEG, the technology being trialled in this study, allows researchers to continuously record EEG in an unobtrusive way for up to 15 months while the person lives their life completely normally.

Trial details

The trial will recruit 33 people with drug resistant epilepsy and implant a miniaturised EEG device under their scalp during a minimally invasive, 20-minute procedure that is performed under local anaesthetic.

Researchers will monitor each person’s brainwaves over six months. By tracking the brainwaves, the experts can accurately count the person’s seizures, allowing 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 at King’s College London, 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.”

Epilepsy facts

Approximately 600,000 people in the UK have epilepsy which is equivalent to around one in 103 people. There are at least 40 different seizure types and people may have one or several varieties.

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.

“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.”


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