Author Of 2 Presentations
P0035 - Can gait modelling predict disease progression in MS? A study using small body worn sensors in a clincial setting. (ID 1377)
Abstract
Background
Accurate assessment of mobility is critical for the clinical management of people with MS (pwMS), and as a biomarker in clinical trials. Small, body worn sensors hold the possibility to provide greater reliability and accuracy than existing clinical tools. Since these sensors can provide a variety of metrics, they have the potential to provide a richer and more holistic assessment of gait impairment than existing clinical tools. Paradoxically however, the sheer number and partial overlap between the metrics provided by these sensors has led to confusion and impeded their clinical translation and acceptability.
Objectives
This study in the first to establish a data driven conceptual model of factors contributing to gait disturbance in pwMS using data obtained from body worn sensors. We then tested the model for its ability to quantify gait differences across different levels of disability and clinical courses of MS.
Methods
We studied 114 pwMS, divided in three groups according to their Expanded Disability Status Scale (EDSS) score. (mild, EDSS ≤ 3.5, moderate, 4.0 ≤ EDSS ≤ 5.5, and severe EDSS ≥ 6), as well as the clinical course of their illness (relapsing remitting or progressive), and 24 healthy controls. Gait was assessed with inertial sensors (OPAL, APDM), located on the lower shanks and on the lower back while they walked for 6 minutes at their self-selected speed along a 10-m path in a hospital corridor.
Results
Thirty-six metrics were initially computed from the sensor data. Twenty of these met quality criteria for exploratory factor analysis, which revealed a gait model consisting of five factors: rhythm/variability, pace, asymmetry, and forward and lateral dynamic balance. After confirming overall goodness with a confirmatory factor analysis, the model was used to investigate differences in gait features across pwMS with different levels of disability. We found significant alterations in rhythm/variability, asymmetry, and pace domains in the mild disability group, which further progressed in the moderate and severe disability group. Dynamic balance, conversely, appeared to be conserved in mild and moderate disability groups, only deteriorating in the severe disability group.
Conclusions
This model of gait in pwMS highlights clinically relevant and differential gait impairment across different clinical disease course and disability levels. The data can be obtained from small body worn sensors in a clinical setting. This approach has potential as an accurate and responsive clinical biomarker in clinical trials and more widely in clinical practise.
P0191 - Autologous Stem Cell Transplantation versus Alemtuzumab or Ocrelizumab in Relapsing Remitting Multiple Sclerosis (StarMS) (ID 359)
Abstract
Background
In recent years, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used to treat patients with highly-active relapsing remitting multiple sclerosis (RRMS) who failed disease modifying therapies (DMTs). Observational and limited clinical trial data suggest that aHSCT reduces relapse rates, improves disability and enhances quality of life to a greater degree than most DMTs. There is now a need to compare aHSCT with the two most efficacious DMTs: Alemtuzumab and Ocrelizumab.
Objectives
StarMS aims to determine whether aHSCT has superior clinical efficacy to Alemtuzumab and Ocrelizumab with an acceptable safety profile. Mechanistic studies will assess immune re-constitution which will enhance understanding of the biological mechanisms of these treatments. Other sub-studies will assess their effect on cognitive recovery, neurofilament light and retinal nerve fibre layer measurements as markers of neuronal damage, and the safety of re-vaccination post-aHSCT.
Methods
This National Institute for Health Research (NIHR) funded parallel-group rater-blinded RCT will randomise 198 patients (1:1) to aHSCT versus DMT (Alemtuzumab or Ocrelizumab) from 19 centres across the UK. The primary endpoint, no evidence of disease activity (NEDA) rate, will be assessed throughout the 2-year follow-up period.
Results
Results are expected to be available in approximately 4 years’ time. Results will be published in peer-reviewed academic journals, presented at relevant conferences, and disseminated via patient groups as applicable.
Conclusions
The StarMS trial has the potential to provide definitive data on the comparative efficacy of aHSCT vs highly efficacious DMTs, help improve patient outcomes, and impact national and international guidelines.
Presenter Of 1 Presentation
P0191 - Autologous Stem Cell Transplantation versus Alemtuzumab or Ocrelizumab in Relapsing Remitting Multiple Sclerosis (StarMS) (ID 359)
Abstract
Background
In recent years, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used to treat patients with highly-active relapsing remitting multiple sclerosis (RRMS) who failed disease modifying therapies (DMTs). Observational and limited clinical trial data suggest that aHSCT reduces relapse rates, improves disability and enhances quality of life to a greater degree than most DMTs. There is now a need to compare aHSCT with the two most efficacious DMTs: Alemtuzumab and Ocrelizumab.
Objectives
StarMS aims to determine whether aHSCT has superior clinical efficacy to Alemtuzumab and Ocrelizumab with an acceptable safety profile. Mechanistic studies will assess immune re-constitution which will enhance understanding of the biological mechanisms of these treatments. Other sub-studies will assess their effect on cognitive recovery, neurofilament light and retinal nerve fibre layer measurements as markers of neuronal damage, and the safety of re-vaccination post-aHSCT.
Methods
This National Institute for Health Research (NIHR) funded parallel-group rater-blinded RCT will randomise 198 patients (1:1) to aHSCT versus DMT (Alemtuzumab or Ocrelizumab) from 19 centres across the UK. The primary endpoint, no evidence of disease activity (NEDA) rate, will be assessed throughout the 2-year follow-up period.
Results
Results are expected to be available in approximately 4 years’ time. Results will be published in peer-reviewed academic journals, presented at relevant conferences, and disseminated via patient groups as applicable.
Conclusions
The StarMS trial has the potential to provide definitive data on the comparative efficacy of aHSCT vs highly efficacious DMTs, help improve patient outcomes, and impact national and international guidelines.