Ultra Long-Term EEG to Guide Rapid Treatment Changes for People with Epilepsy (LEG-RTC)

Epilepsy is common, has high morbidity, significant mortality, and high costs to the NHS. It is often due to an Acquired Brain Injury, such as stroke or hippocampal sclerosis. The burden of epileptic seizures is the key determinant of the impact of epilepsy on physical and mental health. Current state-of-the-art in NHS treatment of epilepsy is for a clinician to judge effectiveness of and therefore consider changes to, drug therapy based on the patient s seizure diary at outpatient visits every few months: NICE epilepsy treatment guidelines emphasise regularly assessing whether treatment is reducing the occurrence of seizures. Strong evidence suggests that patient diaries are extremely unreliable. Therefore, clinicians often make treatment decisions based on deeply inaccurate seizure occurrence information. We will test a novel technology known as EpiSight (formerly 24/7 EEG SubQ) which is manufactured by the Danish technology company UNEEG medical. EpiSight is an unobtrusive, discreet, minimally-invasive ultra-long-term subcutaneous EEG solution that is linked to an automated seizure detection software for objective counting of electrographic seizures. The electrical activity of seizures can be seen in EEG, hence continuously monitoring EEG is the gold standard to count and document seizures. All parts of the solution are CE-marked. EpiSight consists of an implanted electrode and amplifier, and an external data-recorder. The implant measures EEG from two channels. The recorder inductively powers the implant; and receives and stores recorded EEG. The recorder is small, discreet, wireless and is attached to the skin near the site of the implant using a baseplate with an adhesive patch. Data is sent through a secure cloud connection to the hospital, so that the clinician can assess seizure frequency changes whenever they choose. UNEEG EpiSight is a breakthrough innovation, providing a novel solution to the problem of real-world seizure monitoring and is at product development Phase 5 - Commercialization and Rollout. To date, approximately 120 people with Epilepsy have been implanted with the UNEEG solution. Published evidence shows Subcutaneous EEG signal quality is similar to scalp EEG and is highly stable over time1 Subjects find the device easy to use, do not feel limited in their everyday life activities and have high daily adherence of between 18-20 hours per day2 Objective seizure counting leads to a more accurate assessment of seizure burden. Studies comparing subcutaneous EEG to patient diaries have confirmed that patients both under and overreport their seizures3 which can lead to false diagnostic and therapeutic decisions. Subcutaneous EEG recordings have been used to identify seizure cycles4, effect of treatment changes5, assess seizure severity6 and differentiate between psychogenic events and epileptic seizures7. The company has continuously sought the opinions of people with epilepsy, carers, and advocate groups to understand the need for systems which could accurately count seizures, and incorporate those learnings into product design, usability and clinical study design. UNEEG medical has strong links with each of the mainstream Epilepsy charity groups in the UK and continues to seek collaboration with PPI groups at every stage of development.