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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 2 - RADAR-CNS (Remote Assessment of Disease and Relapse in Central Nervous System Disorders - Sofia ref.: 115902)

Teaser

Summary

RADAR-CNS will develop and test a transformative platform of remote monitoring of disease state in three CNS diseases: epilepsy, multiple sclerosis (MS) and depression. The last decade has seen an explosion in the capability of monitoring individuals via sensors in smartphones or wearable devices. The range of parameters which can be measured by such technologies continues to grow. The development of remote measurement technologies (RMT) is an innovation which could be used to predict and avert negative clinical outcomes by providing real time information on the patientâ€™s current clinical state, as well as providing predictive information indicative of a future deterioration. RMT is a disruptive innovation which requires careful evaluation, with an eye kept on implementation in real world settings. CNS disorders are an excellent test bed for such evaluation because they are chronic diseases whose course is dynamic with multiple relapses that could be measured remotely and passively via unobtrusive on-body biosensors and smartphones.

Our ambition is to transform patient care through remote assessment. To achieve this, we will create a pipeline for developing, testing and implementing RMT for depression, MS and epilepsy. We will build an infrastructure to identify clinically useful RMT-measured biosignatures to assist in the early identification of relapse or deterioration, which can be translated into health services. We will develop a platform to identify these biosignatures from well-characterized patient cohorts and will anticipate potential barriers to translation by initiating a dialogue with stakeholders, including patients.

Our specific objectives are:
1. To bring together existing technologies to build a generic RMT platform for smartphone and wearable devices to generate passive and active measurement data using experience sampling methodology (ESM).
2. To devise clinical observational studies to follow patients with specific diseases, stratified by known prognostic indicators, in order to test the acceptability and determine the added value of RMT.
3. To engage stakeholders at the outset to maximise real world use of RMT and to produce relevant questions to inform clinical study design.

Work performed

In the first year collaborations and leadership where developed and a successful management structure was set up shared between KCL, JPNV and Lygature. The main meetings were the kick-off meeting in Brescia (June 2016), the 1st annual consortium meeting in Barcelona (June 2017) and the 2nd annual consortium meeting in Prague (April 2018). We have established Scientific and Patient Advisory boards and appointed an ethics advisor. With all WPs been appointed a WP leadership, the collaboration is working effectively despite its complexity.

In other respects the project is progressing at pace. The translational cluster (WP2, 9 and 10) has concluded the first phase of research determining the acceptability and potential barriers for RMT in people with the conditions under study in RADAR-CNS â€“ MS, epilepsy and MDD. A systematic review summarising previous findings on barriers and facilitators to remote measurement technology across a breadth of health conditions has been accepted for publication. Focus groups in the three disorders and three countries (UK, Italy and Spain) have been completed and analysed by WP2, and a manuscript reporting their findings is under review. There has been strong enthusiasm from patient groups about the potential for RMT and the Patient Advisory Board has been extremely engaged. Detailed care pathway mapping has been completed by WP9 identifying the likely points at which RMT will have greatest clinical utility. And WP10 has mapped out the current regulatory climate for the application of RMT in healthcare. We are also engaging with the European Medicines Agency regarding potential regulatory barriers.
The main technical work packages (WP7 and 8) have now delivered RADAR-base, a platform for the ingestion, storage, analysis and feedback of data from RMT, and developing an analytic framework for future studies. The platform has been successfully deployed first in an in-hospital study of WP4 (epilepsy, study 1). Since November 2017 (i.e. in time) it has been deployed in the first ambulatory community study of depression. During the period November 2017-March 2018 we have been able to test the performance of the platform in clinical studies. This testing phase has been critical in identifying and resolving problems with the software and optimising participant acceptability. We have deliberately limited this testing phase to WP6 (depression) in the KCL site, so that any issues in the platform could be readily addressed because of co-location of WP6 and WP7 teams.
As part of the preparation for the clinical studies we have conducted an extensive scoping exercise led by WP3 to assist in device selection and to identify signals of greatest value â€“ this involved forming 7 thematic working groups which have coordinated efforts to identify the relevant variables to measure within the main RMT modalities (cognition, mood, physical activity, sleep, speech, social interactions and stress).
The clinical work packages (WP3, 4, 5 & 6) have similarly been effective in developing protocols. WP3 has developed the overall assessment scheme for the main studies in the 3 clinical work packages. WP4 has a study under way on the use of RMT to detect seizures in hospitalised epilepsy patients undergoing video-telemetry. After delays at the German site due to the ethics committee requiring the use of a CE marked device, we have successfully recruited 103 participants (April 27th 2018). WP5 has two protocols finalised, has gained ethics approvals from all three sites and is engaged in study initiation. WP6 has gained ethics approval in 2 of the 3 sites (London and Barcelona). There is a delay at the Amsterdam site because of concerns from the ethics committee about the use of a device which was not CE marked for medical use, however the committee has now accepted our argument. We are working to overcome the committeeâ€™s final requests. WP6 has now recruited 34 (April 27th 2018) participants with depression in the London s

Final results

By offering an end-to-end platform capable of data capture, management, modelling and visualization, we will be able to test the acceptability and clinical utility of multimodal RMT. By supporting cheap and widely available devices and where possible passive monitoring, our platform will be scalable to large populations of patients. It also offers the potential for adding new devices, new target outcomes and new diseases. With early engagement from stakeholders our system will anticipate translational and implementational barriers. The clinical management of depression, epilepsy and MS would be readily translated by this technology, with real-time monitoring and an interactive style of communication between patient and clinician. A point of strength of the RADAR-CNS project therefore refers to its potential to translate research findings into both clinical applications and technological opportunities.