NCT06526364

Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)

Clinnova-MS: a Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (Switzerland)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.

Detailed description

Multiple Sclerosis (MS) is a chronic disease of the central nervous system that causes a range of neurological symptoms, such as cognitive issues, fatigue, vision problems, and muscle weakness. There are two main forms: relapsing-remitting MS (RRMS) with episodes of symptoms that improve on their own, and primary progressive MS (PPMS) with chronically worsening symptoms. Many RRMS patients eventually develop secondary progressive MS (SPMS), where disability worsens without remissions. What causes MS remains unknown, but it is thought to involve genetic and environmental factors. Diagnosis and monitoring typically involve patient history, neurologic examination in combination with magnetic resonance imaging (MRI), and other tests, but these methods are costly and time-consuming. Efforts are made to develop digital tools for continuous patients monitoring. This study is part of the Clinnova programme, aiming to collect standardized and high-quality digital health data. Clinnova-MS is a prospective cohort study including patients with early MS or those transitioning to progressive MS. Up to 100 patients, recruited from the ongoing Swiss MS cohort study, are enrolled in Basel, Switzerland. An equivalent number of patients are enrolled in other Clinnova centers, reaching at least 800 patients in total. The study aims to provide a structured and standardized highly granular dataset, allowing for the phenotyping of patients with similar patterns and disease courses. It also facilitates transnational data linkage the analysis of complex and heterogeneous data from MS patients. The primary objective of the study is to derive a set of biomarkers that will better characterize the clinical phenotype and progression of the disease, as well as the functional impairment of MS patients at different stages. These biomarkers will aid clinicians in making informed treatment decisions for patients with early MS or those transitioning to progressive MS.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
OTHER	All participants will be asked to provide data and samples for collection and analysis.	During the first year, data related to demographics, lifestyle, clinical examinations will be collected at baseline, at 6 months (optional) and at 12 months. PROs, cognitive and motor assessments will be performed using the Healios+Me smartphone app. Additionally, participants will be asked to provide biological samples (i.e., blood, cerebrospinal fluid and stool, saliva and hair) and imaging data (if performed as per standard of care). One unscheduled visit may be performed in case the participant comes to the hospital with the occurrence of flare or for a treatment change. A long-term follow-up (FU, starting from month 12 and up to 4 years after month 12) is foreseen in this study. During the long-term FU medical data are collected either every 6 month or on a yearly basis, and PROs are collected every 6 months. Whether study visits are conducted in 6- or 12-monthly intervals depends on the schedule of the study visits for the Swiss MS cohort (SMSC).

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2024-07-29
• Last updated: 2025-12-26

Locations

1 site across 1 country: Switzerland