Using ihMT MRI to assess myelin disruption in multiple sclerosis
Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis
This study is trying out a new MRI technique to see if it can help track changes in myelin for people with early relapsing-remitting multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, PACA) |
| Trial ID | NCT03600779 on ClinicalTrials.gov |
What this trial studies
This project aims to develop in vivo biomarkers that can effectively monitor demyelination and remyelination processes in patients with multiple sclerosis (MS). The study utilizes a novel imaging technique called inhomogeneous Magnetisation Transfer (ihMT), which has shown promise in preliminary studies for its sensitivity in evaluating myelin disruption. By focusing on patients with early relapsing-remitting MS, the study seeks to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions. Participants will undergo MRI scans to assess these processes over time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 45 with relapsing-remitting multiple sclerosis and active lesions on MRI.
Not a fit: Patients with progressive forms of MS or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for monitoring the effectiveness of therapies aimed at repairing myelin in MS patients.
How similar studies have performed: Preliminary studies using similar ihMT techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For Patients and Controls : * Adult patient, male and female, age 18 to 45 * Patient affiliated with health insurance coverage, * Patient who signed a free and informed consent after receiving detailed, understandable and honest information, * For patients only : * Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria * Disease duration of less than 5 years * Patients treated or not treated with first-line disease modifying therapy * Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0) Exclusion Criteria: * For patients only : • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive) * For Patients and Controls : * Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia) * Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position * Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion * Woman who is pregnant and breastfeeding * Patients with a history of neurological or psychiatric condition * Patients under guardianship or trusteeship
Where this trial is running
Marseille, PACA
- Assistance Publique Des Hotipaux de Marseille — Marseille, Paca, France (Recruiting)
Study contacts
- Study coordinator: Jean Pelletier, Md
- Email: Jean.PELLETIER@ap-hm.fr
- Phone: +33 491388204
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.