Using MRI to predict disability progression in multiple sclerosis patients
Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
This study is testing whether advanced MRI scans can help predict if people with relapsing-remitting multiple sclerosis will develop a more serious form of the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT05491031 on ClinicalTrials.gov |
What this trial studies
This study aims to identify MRI biomarkers that can predict the transition from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS). By utilizing ultra-high field 7T magnetic resonance spectroscopy, the study seeks to enhance the visualization of chronic inflammatory lesions and measure brain atrophy with greater precision. The research focuses on analyzing cerebral metabolites to gain insights into cellular energy metabolism and neurodegeneration. This approach could potentially reduce the diagnostic uncertainty associated with SPMS.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of multiple sclerosis lasting up to 25 years and irreversible disability rated at 7 or lower on the EDSS scale.
Not a fit: Patients with other progressive neurological diseases or those who are illiterate and non-French speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of disability progression in multiple sclerosis patients.
How similar studies have performed: While the use of advanced MRI techniques in multiple sclerosis is promising, this specific approach using ultra-high field 7T MRI for predictive biomarkers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years, * Duration of disease ≤ 25 years, * Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale Exclusion Criteria: * Other progressive neurological disease, * Isolated radiologic syndrome (RIS), * Severe psychiatric pathology not in balance, * Change in dosage, discontinuation or initiation of a psychotropic treatment within the last month, * Change in background MS treatment for less than 3 months, * A course of corticosteroids (oral or intravenous) for less than one month, * Patient with a contraindication to MRI: pregnancy, metallic ocular foreign body (accidental splinters or others), pacemaker, implantable defibrillator, neurostimulator not compatible with MRI 7.0 T, cochlear implants and in general any electronic medical equipment implanted in an irremovable way: metallic cardiac valve, vascular clips (formerly implanted on cranial aneurysm), metallic prosthesis...), * Illiterate and non-French speaking patient: patient who is partially or completely unable to read and write French. * Patient benefiting from reinforced protection, i.e. minor, subject deprived of liberty by a judicial or administrative decision, subject staying in a health or social establishment, adult under legal protection and finally patient in emergency situation, * Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
Where this trial is running
Poitiers
- PoitiersUH — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Amelie Dos Santos, Dr
- Email: amelie.dos-santos@chu-poitiers.fr
- Phone: +33.5.49.44.44.46
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.