Actively Recruiting
INsIDER: Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis
Led by University Hospital, Basel, Switzerland · Updated on 2024-12-16
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is a long-term autoimmune condition affecting the central nervous system, causing inflammation and damage to nerve fibers and their protective coverings. This research investigates differences in nerve fiber damage and repair between patients with active MS (aMS) and non-active progressive MS (naPMS) over two years. The study aims to improve understanding of disease progression and support future therapies by using advanced imaging techniques and histopathology to identify specific patterns of nerve damage and healing. Participants will undergo advanced MRI scans at the start and after two years, using multiple imaging methods such as Neurite Orientation Dispersion and Density Imaging (NODDI), Diffusion Kurtosis (DK), Magnetization Transfer Imaging (MTI), and others. These scans provide detailed information on nerve fiber structure, density, and organization. The study includes 200 MS patients (split evenly between active and non-active progressive forms) and 100 healthy volunteers for comparison. Blood samples and neurocognitive tests will also be performed at baseline and follow-up. During the study, participants will have MRI scans and cognitive assessments at baseline and two years later, with a small blood sample taken at the start. Researchers will use machine learning to analyze changes in nerve fiber integrity and organization. Additional tests will assess memory, attention, anxiety, and depression. The study will monitor participants over two years to evaluate how axonal damage and repair evolve in MS and healthy individuals, aiming to enhance disease monitoring and differentiate MS types effectively.
CONDITIONS
Brief Title
Imaging the Interplay Between Axonal Damage and Repair in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with active relapsing-remitting MS with recent clinical relapse or MRI activity, or non-active progressive MS without recent relapse or MRI activity
- Healthy controls without neurological or psychiatric disorders
- Age between 18 and 80 years old
- No other neurological or psychiatric disorders
You will not qualify if you...
- Pregnancy
- Contraindications to MRI such as claustrophobia, metallic implants, or pacemaker
- Inability to give consent
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.
Duration - 1 day
Participants undergo advanced MRI scans and neurocognitive examinations to assess axonal integrity and organization.
1 baseline visit (in-person)
Duration - 2 years (+/- 3 months)
Participants return for follow-up MRI scans and neurocognitive examinations to monitor changes over a two-year period.
1 follow-up visit (in-person) approximately 2 years after baseline
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Department of Neurology
Basel, Switzerland, 4031
Actively Recruiting
Research Team
C
Cristina Granziera, Prof. Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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