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.
Improving lives for patients with 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 (under the skin) implanted electroencephalogram (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
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.
Urgent and unmet need
Rhys Thomas, Clinical Senior Lecturer, Newcastle University and Honorary Consultant in Epilepsy, Royal Victoria Infirmary, Newcastle
“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 people with a learning disability, those 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.
“The REAL-ASE study is a real opportunity for us 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 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.”
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
“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.”
The study will take place in London with support from NHS trial centres in Newcastle, Cardiff, and Manchester.