Actively Recruiting
Application of the Inhomogeneous Magnetisation Transfer MRI Technique to Measure Myelin Changes in Multiple Sclerosis
Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-08-06
85
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying multiple sclerosis (MS), focusing on a new MRI technique called inhomogeneous Magnetisation Transfer (ihMT). This technique is designed to detect changes in myelin, the protective covering of nerves, which is damaged in MS. The study aims to understand how ihMT measures the processes of myelin loss and repair in patients who have just been diagnosed with MS and have active brain lesions. Participants include people newly diagnosed with relapsing-remitting MS and healthy volunteers matched by age and sex. The study uses the ihMT MRI sequence at two different magnetic strengths, 1.5 Tesla and 3 Tesla, to evaluate myelin changes. Different groups undergo these MRI scans to compare results between patients and healthy controls. The study is non-randomized and involves no masking. During the study, participants will have MRI scans to measure outcomes such as ihMT ratio, magnetic transfer, and myelin water fraction at 1.5T and 3T over one year. Researchers will assess the ability of ihMT to predict disease activity and monitor myelin changes. The total study duration extends up to the final evaluation at one year, with safety monitored throughout. Participants must be adults aged 18 to 45 and meet specific health criteria.
CONDITIONS
Brief Title
Application of ihMT MRI in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient, male or female, age 18 to 45
- Affiliated with health insurance coverage
- Signed free and informed consent after full explanation
- Diagnosis of relapsing-remitting multiple sclerosis according to McDonald 2010 criteria
- Disease duration less than 5 years
- Treated or untreated with first-line disease modifying therapy
- At least one active brain lesion detected on initial MRI with post-Gadolinium injection
You will not qualify if you...
- Progressive forms of multiple sclerosis other than early relapsing-remitting (primary or secondary progressive)
- Usual contraindications for MRI such as pacemaker, agitation, metal fragments, or claustrophobia
- Risk of non-compliance due to confusion, involuntary movements, poor tolerance of prolonged supine position
- Unable to give informed consent due to confusion, lack of vigilance, or understanding
- Pregnant or breastfeeding women
- History of neurological or psychiatric conditions
- Under guardianship or trusteeship
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 - Up to 1 year
Participants undergo MRI scans using the inhomogeneous Magnetisation Transfer (ihMT) sequence to evaluate myelin changes in the brain.
Multiple MRI visits over 1 year
Trial Site Locations
Total: 1 location
1
Assistance Publique Des Hotipaux de Marseille
Marseille, PACA, France, 13354
Actively Recruiting
Research Team
J
JEAN PELLETIER, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
Similar Trials
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