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Sponsor: Friedemann Paul

Conditions: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis, Chronic Progressive

Interventions: PASS-MS

Countries: Germany

The study explores the application of marker-less motion analysis (visual-perceptive computing, VPC) using a consumer grade infrared and video camera (Microsoft Kinect) for clinical assessment in MS. It includes as the primary outcomes a short assessment battery of simple motor tasks (PASS-MS) that can be performed in front of the sensor after standard oral instructions given by the operator. For each task, the sensor data are transformed into a set of kinematic parameters that may be used as motor outcome reflecting specific neurological dysfunction. For validation against both clinical and patient-reported outcomes as well as MRI findings, we here prospectively investigate a large cohort of patients with multiple sclerosis. This will allow to determine the usefulness of the various kinematic parameters generated and to define a reduced set of the most meaningful parameters for potential use in future MS trials. Data on repeatability and benchmarks for clinically relevant change are essential to interpret test results and, more importantly, changes thereof. Further, this prospective study will yield estimates of progression rates that are required for planning future studies using this motion analysis tool and assessment battery as an outcome. The study is designed to obtain benchmarks for sensitivity and clinical responsiveness. Primary analysis aims to answer the question: Does the SMSW - Maximum Speed worsen with disease progression established as confirmed disability progression based on EDSS after 24 months (defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS \> 5.5)?