Actively Recruiting
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)
Led by University Hospital, Basel, Switzerland · Updated on 2025-12-26
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
L
Luxembourg Institute of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand Multiple Sclerosis (MS), a chronic condition affecting the nervous system that causes symptoms like cognitive issues, fatigue, vision problems, and muscle weakness. The study focuses on patients with early MS or those moving into progressive phases. It seeks to identify clinical, imaging, and biological markers linked to different stages of MS and to explore digital tools for continuous monitoring of patients as part of the Clinnova programme. Participants with MS will be followed over several years. They will be assessed annually, with an optional 6-month check, and continuously use the Healios+Me smartphone app for digital health measurements. Data collected will include clinical exams, patient-reported outcomes, cognitive and motor tests, biological samples, and imaging data when available. The study includes a long-term follow-up extending up to five years, offering detailed tracking of disease progression and patient function. During the study, participants will attend scheduled visits at baseline, 6 months (optional), and annually for up to five years. Assessments include neurological tests, cognitive evaluations, vision tests, and questionnaires on symptoms, fatigue, mood, and quality of life. Biological samples like blood and cerebrospinal fluid may be collected. Researchers will analyze these data to find biomarkers that better describe MS progression and support treatment decisions. The study is sponsored by University Hospital Basel and aims to enroll around 800 patients across multiple centers.
CONDITIONS
Brief Title
Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willing and able to comply with study procedures including data and sample collection
- Signed informed consent form
- Owns a smartphone compatible with the Healios+Me app (iOS or Android)
- Corrected close visual acuity of 0.5 or better
- Hand motor skills sufficient to use a smartphone
- Ability to follow all study procedures
- Diagnosed with Multiple Sclerosis according to revised McDonald criteria 2017, including clinically isolated syndrome, RRMS, SPMS, or PPMS
- In early disease stages (less than 3 years) or transitioning to progressive disease
- Enrolled in the Swiss MS Cohort at University Hospital Basel
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessments
Participants undergo clinical examinations, imaging if performed as standard of care, and provide biological samples for analysis to characterize their disease status.
1 baseline visit (in-person)
Duration - 1 year
Participants are monitored through clinical assessments, patient-reported outcomes, cognitive and motor tests using the Healios+Me smartphone app, and biological sample collection to track disease progression.
Visits at 6 months (optional) and 12 months; continuous digital assessments via smartphone app
Duration - Up to 4 years after month 12
Participants continue to provide medical data and patient-reported outcomes every 6 or 12 months for up to 4 years after the first year to observe disease progression and outcomes.
Visits every 6 or 12 months depending on cohort schedule; PROs collected every 6 months
Trial Site Locations
Total: 1 location
1
Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)
Basel, Switzerland, 4031
Actively Recruiting
Research Team
B
Bebeka Cosandey (Clinnova:Scientific Project Lead), PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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