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Sensitivity of Motor Assessment in MS - a Prospective Cohort Study

NCT04993274 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-08-10

No results posted yet for this study

Summary

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)?

Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Secondary Progressive
  • Multiple Sclerosis, Chronic Progressive

Interventions

DIAGNOSTIC_TEST

PASS-MS

protocol using short motor tasks performed by the subject and recorded by a depth camera, motion analysis by visuo-perceptive computing

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Friedemann Paul

    lead OTHER

Principal Investigators

  • Friedemann Paul · Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04993274 on ClinicalTrials.gov