NCT05491031

MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Magnetic Resonance Spectroscopy

Interventions

Type	Name	Description
OTHER	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)

Timeline

• Start date: 2023-04-25
• Primary completion: 2028-01-01
• Completion: 2028-05-01
• First posted: 2022-08-08
• Last updated: 2023-09-14

Locations

1 site across 1 country: France