JMIR Publications

ABSTRACT

Background:

In recent years a growing body of literature has highlighted the role of wearable and mobile remote measurement technology (RMT) applied to seizure detection in hospital settings, whilst more limited evidence has been produced in the community setting. In clinical practice, seizure assessment typically relies on self-report, which is known to be highly unreliable. Moreover, most people with epilepsy self-identify factors which lead to increased seizure likelihood, including mood, behavior, sleep pattern and cognitive alterations, which are all amenable to measurement via multi-parametric RMT.

Objective:

RADAR-Epilepsy is a multi-centre prospective cohort study, primarily aiming at assessing the usability, feasibility and acceptability of RMT in the community setting. In addition to this, we will determine whether multi-parametric RMT collected in populations with epilepsy can prospectively estimate variations in seizure occurrence and other outcomes, including seizure frequency, quality-of-life and comorbidities.

Methods:

People with a diagnosis of pharmaco-resistant epilepsy will be recruited in London, UK and Freiburg, Germany. Participants will be asked to wear a wrist-worn device and download ad-hoc developed apps onto their smartphones. The apps will be used to collect data related to sleep, physical activity, stress, mood, social interaction, speech patterns and cognitive function, both passively from existing smartphone sensors (passive RMT) and actively via questionnaires, tasks and assessments (active RMT). Data will be collected continuously for 6 months and streamed to RADAR-base server.

Results:

The RADAR-CNS project has received funding in 2015 from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115902. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. Ethical approval has been obtained in London from the Bromley Research Ethics Committee (REC reference: 19/LO/1884) in January 2020. The first participant will be enrolled on the 30th September 2020. Data will be collected until the 30th of September 2021. The results are expected to be published at the beginning of 2022.

Conclusions:

RADAR-Epilepsy is aimed at developing a framework of continuous data collection intended to identify ictal and pre-ictal state through the use of active RMT and passive RMT in the real-life environment. The study has been specifically designed to primarily evaluate the clinical usefulness of the data collected via new technologies as well as compliance, technology acceptability and usability for patients. These are key aspects to a successful adoption and implementation of RMT as a new way to measure and manage long-term disorders.