MSpine: a prospective longitudinal study of spinal cord lesions in multiple sclerosis: MRI monitoring and prognostic factors for active disease. A study protocol

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system. Over the past years, spinal cord MRI (SC-MRI) has improved significantly in quality and has become an important part of the diagnostic workup for MS. Presently, follow-up imaging of the spinal cord is mainly performed when spinal cord related symptoms occur. However, there is increasing evidence that asymptomatic cord lesions can occur independently of brain disease activity. Even asymptomatic spinal cord lesions have been shown to be a poor prognostic factor regarding future disability accrual. Additionally, the association between (asymptomatic) spinal cord lesions and progression independent of relapse activity (PIRA) remains undefined. Prospective data on the frequency and importance of asymptomatic spinal cord lesions, and therefore the potential role of SC-MRI in treatment monitoring, is lacking. We will routinely scan the whole spinal cord (as well as routine brain MRI) to prospectively collect SC-MRI data, in addition to clinical parameters, blood-biomarkers and CSF, in recently diagnosed MS patients. The goal is to assess the incidence of asymptomatic spinal cord lesions in patients commencing disease modifying treatment (DMT) for the first time. It will be assessed how often disease activity is solely proven by SC-MRI. A secondary objective is to identify patient groups predisposed to developing new spinal cord lesions during follow-up in early disease. This will be a multicentre, prospective longitudinal, observational study. The study population consists of relapsing-remitting MS patients, between 18 and 65 years old, initiating their first DMT within 5 years of the first clinical event. We aim to include 155 patients, who will receive three yearly SC-MRI (both sagittal and axial), brain MRI and biomarker assays during follow-up of 27 months. This study started in August 2024. Currently, inclusion is still ongoing. The goal of this study is to explore the incidence of asymptomatic spinal cord lesions in early MS and to identify prognostic factors for spinal cord disease activity. This study has been registered in the Dutch CCMO/OMON Registry under NL-005846 at 12/03/2024 ( https://onderzoekmetmensen.nl/nl/trial/56629 ) and in ClinicalTrials.gov under registration number NCT06827834.