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

NCT ID: NCT06526364

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2029-06-30

Brief Summary

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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

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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

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

Keywords

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Immune-meditated Diseases Artificial Intelligence Personalized medicine Treatment change Phenotyping Clinnova

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MS patients

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.

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

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Luxembourg Institute of Health

OTHER_GOV

Sponsor Role collaborator

Research Center for Clinical Neuroimmunology and Neuroscience Basel

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristina Granziera, Prof.

Role: PRINCIPAL_INVESTIGATOR

Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Locations

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Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Bebeka Cosandey (Clinnova:Scientific Project Lead), PhD

Role: CONTACT

Phone: +41 79 961 26 31

Email: [email protected]

Facility Contacts

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Bebeka Cosandey (Clinnova:Scientific Project Lead), PhD

Role: primary

Related Links

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https://www.clinnova.eu/en/

CLINNOVA website

Other Identifiers

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2023-01640; ko23Granziera

Identifier Type: -

Identifier Source: org_study_id