magnetic resonance spectroscopy: Investigation of the association, in patients with multiple sclerosis, between MRI biomarker data at inclusion and progression of physical disability during follow-up (6, 12, 18 and 24 months) assessed by a composite endpoint EDSS plus (EDSS, 9HPT, T25FW)
Study summary
The transition from relapsing-remitting multiple sclerosis to secondarily progressive multiple sclerosis (SPMS) is difficult to identify. Typically, SPMS is diagnosed retrospectively, with a significant delay, on the basis of a clinical history of progressive worsening, independent of relapses. Thus, SPMS is often associated with a considerable period of diagnostic uncertainty.
The use of ultra-high field imaging can shed light on the mechanisms of disability progression thanks to its better spatial resolution and advanced imaging techniques.
The new morphological imaging techniques make it possible to visualize chronic inflammatory lesions and to evaluate their evolution. It also allows for the precise measurement of brain atrophy, a reference in the evaluation of neurodegeneration.
Metabolic imaging via proton spectroscopy allows the analysis of several promising cerebral metabolites that can provide information on cellular energy metabolism, mitochondrial function, or oxidative stress, and can help identify tissues at risk of neurodegeneration. Sodium imaging can provide information on axonal energy metabolism before the occurrence of stable and irreversible axonal damage. This technique is promising as an early marker of neurodegeneration.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Identify imaging biomarkers at inclusion predictive of disability progression. — up to 24 months Determine the correlation between biomarkers concentrations (in mmol/L) with physical disability at inclusion and during follow-up (6, 12, 18 and 24 months) in patients with multiple sclerosis.
Physical disability is assessed by an Expanded Disability Status Scale plus (EDSS-plus). EDSS-Plus defined as progression on ⩾1 of 3 components (T25FW, 9HPT, EDSS). EDSS score is ordinal rating system ranging from 0 (normal neurological status) to 10 (death), Timed 25-Foot Walk test (T25FW) (second) and 9-Hole Peg Test (9HPT) based on the time for patient to take the 9 pegs and place them in the holes (second).
Trial sites (1)
Facility
City
Region
Status
PoitiersUH
Poitiers
France
Recruiting
More Poitiers University Hospital trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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