Artificial intelligence for personalised
therapy solutions

The Clinnova-MS study: Cross-national data linkage to analyse complex and heterogeneous data from MS patients

Background

Multiple sclerosis (MS) is the most common immunological disorder of the nervous system (> 1 in 1000 people) predominantly affecting women. The disease represents a leading cause of permanent disability in young adults and impacts the central nervous system resulting in a variety of neurological symptoms. Several approved disease-modifying MS drugs are available. However, there is often a lack of reliable information to support doctors in prescribing the optimal therapy at the right time. The need for personalised clinical management is evident.

Solutions based on artificial intelligence (AI) harbour great potential for precision medicine. So far, however, they have not yet lived up to expectations. The Clinnova programme is intended to address these challenges:  Based on a cross-regional collaboration between institutions from Basel, France, Germany and Luxembourg, it aims to promote the digitalisation of the healthcare system and to develop the potential of AI applications by improving the personalised treatment of chronic inflammatory diseases. The Clinnova consortium focuses on three chronic inflammatory autoimmune diseases of high medical need: multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

Research question

The Clinnova-MS study is part of the Clinnova programme and aims to establish a prospective MS patient cohort. Using data from participating study centres, a structured, standardised and highly differentiated data set will be created utilising existing methods from related research projects such as the Swiss MS Cohort Study (SMSC). This data will be analysed in a federated learning platform. The platform will enable the training and development of AI algorithms which will be used to devlop personalised treatment solutions for patients, to identify features associated with early MS and transition phases to progressive MS and to validate digital biomarkers which will make continuous monitoring of MS patients possible.

Study methodology

Clinnova-MS will enrol patients with beginning MS or patients in the transition phase to progressive MS. Up to 100 patients will be enrolled at the University Hospital Basel and a comparable number at the other Clinnova centres. Personal data and samples from study participants will be collected and analysed as well as data from follow-up visits over five years. "Patient Reported Outcomes" as well as cognitive and mobility measurements will be recorded using the smartphone application "dreaMS" which is currently being developed and validated at the RC2NB. Biological samples (blood, cerebrospinal fluid and stool) and imaging data will initially be stored locally and then transferred to the data centre in Luxembourg, the main centre responsible for the Clinnova project. The data will be analysed using a federated machine learning platform. This machine learning technique enables algorithms to be trained on data sets from different clinical sites without sharing sensitive data.

Significance of the study

As part of the Clinnova consortium, Clinnova-MS will allow to detect changes in MS disease progression based on standardised and high-quality digital health data and thus guide targeted interventions. The aim is to identify personalised therapeutic approaches through AI stratification in order to improve the quality of life of those affected. At the same time Clinova-MS has the potential to reduce costs in the healthcare system.

Contributors

Prof. Ludwig Kappos (RC2NB, University Hospital Basel)
Prof. Jens Kuhle (RC2NB, University Hospital Basel)
PD Dr. Lars G. Hemkens, MPH (RC2NB, University Hospital Basel)
Dr. Bebeka Cosandey (RC2NB, University Hospital Basel)
Dr. Amandine Bovay (University of Basel)
Dr. Bram Stieltjes (University Hospital Basel)
Dr. Thierry Sengstag (Unverity of Basel)

DKF-Services

Methodological Consulting, Project Management, Regulatory Affairs

November 2023

Principle Investigator
Prof. Dr. med. Dr. phil.
Cristina Granziera

Chief Physician Neurology, University Hospital Basel
Co-Head RC2NB

Specialisation
Neuroimmunology, Neurology, Neuroimaging, Digital methods

Research area
Neuroimaging, Digital neurology, Pathogenesis of neuroinflammatory, cerebrovascular and neurodegenerativ diseases; Personalised medicine; Biomedical Engineering

Scientific and clinical track  (selection)
since 2023: Co-Head Research Center for Clinical Neuroimmunology and Neuroscience, Basel (RC2NB)
since 2019: Chief Physician, Neurology, University Hospital Basel
since 2018: SNF Assistance Professorship for Neurology and Bioengineering, University of Basel, University Hospital Basel and Research Center for Clinical Neuroimmunology and Neuroscience, Basel (RC2NB)
2017 – 2018: Senior Physician, Neurology, University Hospital Basel
2015 – 2017: Assistant Physician for Biomedical Engineering and Assistant Professor in Radiology, Massachusetts General Hospital and Harvard Medical School, Boston (USA)
2014 – 2018: Lecturer, Centre Hospitalier Universitaire Vaudois, Lausanne
2011 – 2014: Lecturer and Senior Physician, Neurology, Centre Hospitalier Universitaire Vaudois, Lausanne
2010 – 2011: Research Fellow, Ecole Polytechnique Fédérale de Lausanne

© Departement of Clinical Research, University of Basel c/o University Hospital Basel, November 2023