MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years,
Duration of disease ≤ 25 years,
Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
magnetic resonance spectroscopy
Other interventionInvestigation 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)
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Multiple sclerosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Identify imaging biomarkers at inclusion predictive of disability progression.
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).
Time frame
up to 24 monthsSecondary outcomes
1
Determine the correlation between brain MRI and the concentration of imaging biomarkers (mmols) at 6, 12, 18 and 24 months.
Time frame
up to 24 months2
Develop realistic mathematical models of disease progression associated with clinical assessment of disability through dynamics, by the EDSS-plus score (EDSS scale from 0 to 10, T25FW in seconds, 9HPT in seconds).
Mathematical models of disease progression using the concentration of biomarkers (in mmol) associated with clinical evaluation of disability (EDSS-plus) over a dynamic period.
Time frame
up to 24 months3
Develop an artificial intelligence algorithm to identify predictive markers for disability. The artificial intelligence algorithm utilizes patients' clinical (EDSSS-Plus Scale) and radiological (brain MRI) characteristics.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov