Observational study of patients with Multiple Sclerosis in 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)
This study is trying to find out more about the early signs of Multiple Sclerosis and how it changes over time by looking at health data from patients in Switzerland.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06526364 on ClinicalTrials.gov |
What this trial studies
This observational cohort study, part of the Clinnova programme, aims to identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and the transition to progressive MS. It will also investigate digital biomarkers for continuous clinical monitoring of patients. Up to 100 patients with early MS or transitioning to progressive MS will be recruited from the Swiss MS cohort study in Basel, with a total target of at least 800 patients across multiple centers. The study focuses on collecting standardized digital health data to enable detailed phenotyping of patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with any form of MS within the first three years of disease onset or those transitioning to progressive MS.
Not a fit: Patients with advanced stages of MS or those not enrolled in the Swiss MS cohort study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and personalized treatment strategies for patients with Multiple Sclerosis.
How similar studies have performed: Other studies have shown promise in using digital tools for monitoring MS, but this approach is part of a novel initiative within the Clinnova programme.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Basel
- Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Cristina Granziera, Prof. — Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
- Study coordinator: Bebeka Cosandey (Clinnova:Scientific Project Lead), PhD
- Email: bebeka.cosandey@usb.ch
- Phone: +41 79 961 26 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.