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

University Hospital Basel

Status: Enrolling

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis, Primary Progressive

Treatments: Other: All participants will be asked to provide data and samples for collection and analysis.

Study type: Observational

Funder types: Other

Identifiers

NCT06526364

2023-01640 ko23Granziera;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age ≥18
• Participants are willing and able to comply with the protocol, including undergoing data and samples collection as well as study visits and examinations.
• Signed informed consent form
• In possession of a Healios+Me app compatible smartphone (iOS/Android)
• Corrected close visual acuity of ≥0.5
• Hand motor skills sufficient for using a smartphone
• Ability to follow the study procedures
• Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (clinically isolated syndrome, RRMS, SPMS, PPMS) AND early disease stages (< 3 years) OR transitioning phase to progressive disease as evaluated based on Expanded Disability Status Scale (EDSS).
• Enrolled in the SMSC at University Hospital Basel

There are no specific exclusion criteria.

Trial design

100 participants in 1 patient group

MS patients

Description:

MS patients, recruited from the SMSC, are annually (optional 6-monthly) assessed and additionally, perform digital measurements with the Healios+Me app continuously after baseline up to 5 years as an optional follow-up study extension.

Treatment:

Other: All participants will be asked to provide data and samples for collection and analysis.