Public Funding for Neuronostics Limited

In this project Neuronostics will demonstrate how computer analysis can reveal important information about treatment response for people with epilepsy. At present when someone is told they have epilepsy, they start taking drugs. However, we have no way of knowing whether or not they will continue to have seizures, accept by waiting to see. This is unpleasant for the person and exposes them to risk. The more seizures they have, the poorer their overall outcomes. To address this challenge Neuronostics have generated a tool that can indicate how likely someone is to have active epilepsy. The tool, called BioEP, uses computer algorithms to analyse electrical activity of the brain that doctors record using a device called an EEG machine. In this project Neuronostics will work with 4 hospitals in the UK to understand what happens to the BioEP rating when people with epilepsy start taking drugs. In an early study Neuronostics have shown that the BioEP rating reduces in cases where the treatment works, but does not change in cases where treatment fails. This project will conduct a clinical study to confirm these early findings. Alongside the study, Neuronostics will use the data generated to update their computer tool, to engage with doctors to understand how they would use the tool in clinic and to undertake activities necessary to regulate the tool for use to measure treatment response. If the project is successful, Neuronostics anticipate the tool being available for clinical use by mid 2028, resulting in thousands of people in the UK having access to information that will confirm if their treatment is working.

Our proposal is focussed on Epilepsy: a serious neurological condition. Epilepsy is characterised by the tendency to have repeated, spontaneous, seizures. Since seizures occur seemingly at random, epilepsy diagnosis is very challenging. The electroencephalogram (EEG) is an important clinical tool for revealing abnormalities that indicate epilepsy. However, around 70% of recorded EEGs provide no clinical indication of epilepsy. Consequently, diagnostic delays regularly exceed a year and the rate of misdiagnosis is estimated at 30%. The cost of this misdiagnosis has been estimated at over £300M annually to the NHS. To address this challenge, Neuronostics have developed a computer Biomarker ofEpilepsy: BioEP. BioEP works by integrating routinely acquired EEG into a computer model of the brain. Simulations of this model, interrogated using advanced machine learning algorithms, provide a risk score showing how easy it is for seizures to occur. For EEGs currently considered clinically non-contributory, the BioEP risk score provides valuable additional diagnostic information. Research underpinning BioEP has been recognised by the Lancet Neurology (as a breakthrough study in epilepsy in 2015), the Epilepsy Foundation (through a commercialisation prize in 2017) and Nature (Neuronostics was one of the final four in the SpinOff Prize 2021). Through Innovate UK and NIHR funding, Neuronostics have developed a prototype of a diagnostic decision support tool powered by BioEP, that enables semi-automated feature extraction and report writing. Neuronostics have recently completed a retrospective study (using data from people with a known and accurate diagnosis) to validate the performance of the BioEP. The largest study of its kind, we demonstrated that BioEP can reveal susceptibility to epilepsy in apparently normal EEGs at a level that out performs current clinical practice. In the current project, we will undertake a prospective study to demonstrate the clinical utility of the BioEP risk score. We will conduct a multi-site study where people with suspected epilepsy will go through the normal care pathway, but in half the cases we will additionally provide the BioEP risk score. We will compare the time to working diagnosis, the types of diagnosis made, and the confidence of the clinician in the decision made in each arm. This will enable us to understand the impact BioEP has on the key clinical outcomes of time to diagnosis, accuracy and objectivity of decision making, as well as confidence in the decision reached.

We will develop a mobile app for people with epilepsy. The app will empower people with epilepsy to best manage their condition within the home environment, whilst contributing to their sense of purpose through voluntary epilepsy research involvement. In response to the COVID-19 crisis, we conducted a global survey of people with epilepsy. We received over 150 responses, including nearly 100 from the UK alone, between April 7th and 14th. Our survey revealed concerns about the impact of isolation on stress, mental health and anxiety, memory and sleep, with consequences for drug adherence and seizure control. Our survey further revealed connecting with researchers and healthcare providers as important priorities for people with epilepsy. Being empowered with relevant information and contributing both to management of their own condition and a broader research effort to understand epilepsy, were considered very important for reducing the impact of isolation due to COVID-19. #ConnectEP will be developed in partnership with globally renowned epilepsy advocates, researchers, clinicians and charity partners. It will be an important resource for delivering up-to-date information, recording relevant information, access to latest research findings, and the ability to contribute to research and clinical studies. In response to the challenges of isolation raised by COVID-19, raised by our community survey, our immediate focus will be on stress and mental health, drug adherence, sleep and seizure occurrence. During the initial phase of the project, we have connected with a number of charities and organisations who are interested in developing data-driven projects, but who have not been able to develop sustainable business models around these. Extension for Impact funding will enable us to explore and formalise these relationships with partners whose missions are synergetic with the #ConnectEP app. As an example, during the initial phase of the project, we have developed a partnership with a leading UK research charity. #ConnectEP will provide a direct connection between the app’s user base and researchers who are either seeking funding from the charity or seeking participants for charity-funded projects. With this bespoke functionality, #ConnectEP will enable people with epilepsy to engage directly with researchers linked with the charity to help prioritise ideas for funding or become involved in studies.

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Epilepsy is a serious neurological condition that affects almost 1% of the population at some stage in their lives. It is a condition with high economic (£15bn annually across Europe) and social (>1000 deaths annually in the UK) costs. In this project, Neuronostics seeks to demonstrate proof of concept for its lead product, BioEP. BioEP is a novel precision medicine tool that can identify whether or not someone has epilepsy and whether or not they are responding to treatment. In contrast to current clinical practice, which can only answer these questions if seizures occur whilst being monitored clinically, BioEP uses advanced mathematical and computational algorithms to interrogate the electrical activity of the brain and reveal susceptibility to epilepsy. BioEP additionally offers the potential to determine whether or not someone is responding effectively to treatment. For the millions of people with epilepsy worldwide BioEP offers the opportunity for fast, effective and objective clinical decision making.