4 September 2023

Multiple sclerosis: Better tracking of disease progression and management of therapy using digital biomarkers

The dreaMS app: from successful feasibility study to validation of the smartphone application

Background of the project

The Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) has dedicated itself to developing digital tools to map and characterise the course of multiple sclerosis (MS). This knowledge will then be used to guide therapy decisions in terms of personalised disease management.

The "dreaMS" project is investigating the use of a smartphone application developed in collaboration with Basel-based Healios AG. The application enables the measurement of various functions often affected in MS directly with and on the patient, using the sensors already integrated in our smartphones and smartwatches. By performing short exercises with these devices, potential digital biomarkers can be derived from the measurement results. Data will be collected on movement, balance and fine motor skills, vision, as well as cognitive functions such as memory, spatial orientation, attention and reaction time. Information from questionnaires on mood, fatigue and quality of life are also included in the surveys. Special sensors are also used to continuously record information such as step count, general movement profile, heart rate and sleep behaviour.

Real-life scenario

The advantage of these digital biomarkers is that the information can be collected continuously and in near real time. This can complement, and in some cases replace, regular clinical examinations, as the exercises and tests take place in the patient's natural environment. Processing the data with objective algorithms also allows a more structured approach and better comparability.

More about the dreaMS app in the following video (© RC2NB & Healios AG, 2022):

Phase 1: Feasibility confirmed

In a first phase, the dreaMS app was tested on both people with MS and healthy volunteers, confirming its feasibility. The results have recently been published in two papers in the Journal of Neurology:

Woelfle et al, 2022 describe how the measurements collected by the dreaMS app could be reliably measured. They also asked participants for their opinions on the tests used, which were found to be meaningful for MS.

Pless et al, 2023 reported on the comparison of information on participants' performance in ten cognitive games included in the dreaMS app with the results of reference neuropsychological tests. Good agreement was found. All games were also perceived as entertaining and meaningful by the participants, which is an important indicator for long-term use in clinical practice.

Phase 2: Validation study underway

The first validation study is now underway with up to 300 people with MS from the Swiss MS Cohort Study (SMSC) and 50 healthy volunteers who will use the dreaMS app for a total of two years. The data will be validated using established testing methods. Recruitment for the validation study is on track. To date, 130 people with MS have been enrolled.

In order to obtain truly reliable and generalisable results, the results will then need to be replicated in an international, multi-centre validation study. The researchers are confident that they will achieve this goal and pave the way for the app to enter clinical practice.

Challenges

The requirements for conducting a study leading to approval as a medical device are high. Similar rules apply as for the development of a new drug, and since sensitive personal data is involved, the highest demands are placed on data processing and data protection. Overall, the volume of data generated and its complexity pose a particular challenge. The app data is first secured in the cloud and transmitted end-to-end encrypted to the University Hospital in Basel. There it is merged with encrypted medical data and analysed.

In addition to the RC2NB study team led by PD Dr. med. Johannes Lorscheider, Prof. Dr. med. Cristina Granziera and Prof. Dr. med. Ludwig Kappos, the scientific service teams Data Management, Data Analysis and Regulatory Affairs of the DKF are involved in the project.