Actively Recruiting

Age: 18Years +
All Genders
ID06526364

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Monitoring

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

Functional Assessment of Balance and Gait and Correlation Wi...

Multiple Sclerosis

Actively Recruiting

2 locations

"Selfie" Videos: A Novel, Patient-centered, Comprehensive Ap...

Multiple Sclerosis

Actively Recruiting

1 location

3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal ...

Multiple Sclerosis

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here