Abstract

Background and Objective: In multiple sclerosis (MS) patients, Double Inversion Recovery (DIR) magnetic resonance imaging (MRI) can be used to detect cortical lesions (CL). While the quantity and distribution of CLs seems to be associated with patients' disease course, literature lacks frequent assessments of CL volumes (CL-V) in this context. We investigated the reliability of DIR for the longitudinal assessment of CL-V development with frequent follow-up MRIs and examined the course of CL-V progressions in relation to white-matter lesions (WML), contrast enhancing lesions (CEL) and clinical parameters in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).Methods: In this post-hoc analysis, image- and clinical data of a subset of 24 subjects that were part of a phase IIa clinical trial on the “Safety, Tolerability and Mechanisms of Action of Boswellic Acids in Multiple Sclerosis (SABA)” (ClinicalTrials.gov, NCT01450124) were included. The study was divided in three phases (screening, treatment, study-end). All patients received 12 MRI follow-up-examinations (including DIR) during a 16-months period. CL-Vs were assessed for each patient on each follow-up MRI separately by two experienced neuroradiologists. Results of neurological screening tests, as well as other MRI parameters (WML number and volume and CELs) were included from the SABA investigation data.Results: Inter-rater agreement regarding CL-V assessment over time was good-to-excellent (κ = 0.89). Mean intraobserver variability was 1.1%. In all patients, a total number of 218 CLs was found. Total CL-Vs of all patients increased during the 4 months of baseline screening followed by a continuous and significant decrease from month 5 until study-end (p < 0.001, Kendall'W = 0.413). A positive association between WML volumes and CL-Vs was observed during baseline screening. Decreased CL-V were associated with lower EDSS and also with improvements of SDMT- and SCRIPPS scores.Conclusion: DIR MRI seems to be a reliable tool for the frequent assessment of CL-Vs. Overall CL-Vs decreased during the follow-up period and were associated with improvements of cognitive and disability status scores. Our results suggest the presence of short-term CL-V dynamics in RRMS patients and we presume that the laborious evaluation of lesion volumes may be worthwhile for future investigations.Clinical Trial Numbers: www.ClinicalTrials.gov, “The SABA trial”; number: NCT01450124

Highlights

  • Recent clinical trials, neuropathological investigations and magnetic resonance imaging (MRI) imaging studies have drawn growing attention to the relevance of gray matter (GM) lesions and cortical lesions (CL) in Multiple Sclerosis (MS) patients [1,2,3]

  • Our study model intrinsically does not hold a control group

  • Double Inversion Recovery (DIR) MRI seems to be a reliable tool for the assessment of CL volumes (CL-V) development over time

Read more

Summary

Introduction

Neuropathological investigations and MRI imaging studies have drawn growing attention to the relevance of gray matter (GM) lesions and cortical lesions (CL) in Multiple Sclerosis (MS) patients [1,2,3]. We had access to a subset of longitudinal MRI data from the phase IIa trial on the “Safety, Tolerability and Mechanisms of Action of Boswellic Acids (BA) in Multiple Sclerosis (SABA)” [17] This subset of RRMS patients underwent 12 MRI follow-up examinations (including DIR sequences) within a 16-months period enabling assessments of CLs at high sampling rates. We investigated the reliability of DIR for the longitudinal assessment of CL-V development with frequent follow-up MRIs and examined the course of CL-V progressions in relation to white-matter lesions (WML), contrast enhancing lesions (CEL) and clinical parameters in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). All patients were treated with BA doses up to 1,500 mg/3 times a day and received no corticosteroids or other immunomodulating substances for at least 3 months before entering the study

Objectives
Methods
Results
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call