Multimodal Exploration of Patients With Multiple Sclerosis for an Early Detection of Subtle Progression
- Conditions
- Multiple Sclerosis
- Interventions
- Device: Visual Evoked Potential (VEP)Device: Somatosensory evoked potential (SSEP)Device: Transcranial magnetic motor evoked potentials (TCmMEP)Device: Tesla Brain MRIDiagnostic Test: Blood test - Neurofilament light chain (NfL)Diagnostic Test: Blood test - EBV serology
- Registration Number
- NCT05941975
- Lead Sponsor
- Brugmann University Hospital
- Brief Summary
Multiple sclerosis (MS) is a chronic inflammatory and degenerative disease of the central nervous system (CNS), characterized by a complex interplay of inflammatory demyelination and neuronal damage. The core MS phenotypes defined by clinical course are the relapsing and the progressive forms.Relapsing MS (RMS) is characterized by attacks - also called relapses - defined as new or increasing neurologic dysfunction, followed by periods of partial or complete recovery, without apparent progression of the disease during the periods of remission. In contrast, progressive MS (PMS) is characterized by progressive worsening of neurologic function leading to accumulation of disability over time independent of relapses. Additional descriptors ("active/not-active") serve to better characterize the presence of clinical and/or radiological activity both in relapsing and progressive forms.
In recent years, the concept of a silent progression, also known as smouldering MS, is making its way into the common lexicon of MS experts, challenging the current definitions of MS phenotypes. A growing body of literature suggests that the line between RMS and PMS is not as marked as men thought, and that inflammation and neurodegeneration can represent a single disease continuum coexisting early on in the disease course. Whilst it is established that relapse-associated worsening (RAW) can be accounted for by an acute inflammatory focal damage leading to axonal transection and conduction block, the physiopathology underlying the progression independent of relapse activity (PIRA) remains unclear.
It is becoming apparent that there is an increasing need for a personalized therapeutic approach by considering the individual MS phenotype of each patient, thereby enabling the choice of the molecule best suited to counteract the predominant disease pattern of that individual patient.
There is a limited number of studies combining clinical scores, neurophysiological evaluation and neuroimaging in patients with MS experiencing PIRA. Integrating a multimodal exploration of these patients might allow a step forward in the early recognition, management, and treatment of disability accumulation independent from relapses in patients with MS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients ≥ 18-year-old with diagnosis of RMS according to 2017 McDonald diagnostic criteria
- Availability in the functional outcome database of at least 3 time-point complete evaluations with a time frame from the first to the last evaluation of minimum 12 months
- Most recent functional outcome evaluation within 12 months of enrollment
- Availability of follow-up MRI data during the observational period
a) Contraindication to one or more of the paraclinical tests of the prospective multimodal evaluation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PIRA Visual Evoked Potential (VEP) From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) N-PIRA Tesla Brain MRI From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA) N-PIRA Blood test - EBV serology From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA) PIRA Somatosensory evoked potential (SSEP) From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) N-PIRA Visual Evoked Potential (VEP) From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA) N-PIRA Transcranial magnetic motor evoked potentials (TCmMEP) From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA) PIRA Tesla Brain MRI From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) PIRA Blood test - EBV serology From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) N-PIRA Blood test - Neurofilament light chain (NfL) From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA) PIRA Transcranial magnetic motor evoked potentials (TCmMEP) From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) PIRA Blood test - Neurofilament light chain (NfL) From the MS functional outcome database, identification of a cohort of patients with RMS experiencing progression independent of relapse (PIRA) N-PIRA Somatosensory evoked potential (SSEP) From the MS functional outcome database, identification of a cohort of patients with RMS not experiencing progression independent of relapse (N-PIRA)
- Primary Outcome Measures
Name Time Method Epstein-Barr virus (EBV) serology (VCA IgG) 12 months after baseline EBV serology will be assessed (VCA IgG) in the serum of patients to evaluate the variation of antibody titers over time (at baseline, at 6- and 12-month follow-up), and compare to titers at the time of diagnosis (when available in their medical record).
Visual Evoked Potential (VEP) Change from baseline to 12 months To assess the integrity of visual pathways through the optic nerves to the visual cortex.
Somatosensory evoked potential (SSEP) Change from baseline to 12 months To assess the integrity of sensitive pathways through the peripheral nerves and dorsal spinal cord to the somatosensory cortex.
Transcranial magnetic motor evoked potentials (TCmMEP) Change from baseline to 12 months To measure the integrity of motor pathways.
Tesla Brain MRI Baseline Tesla Brain MRI (descriptive outcome)
Neurofilament light chain (NfL) serum levels 12 months after baseline Neurofilament light chain (NfL) serum levels
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Brugmann
🇧🇪Brussels, Belgium