Sensitivity of Motor Assessment in MS - a Prospective Cohort Study

NCT04993274 | Unknown

• 1 other identifier: EA1/240/18
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multiple sclerosis; gait; balance; postural control; progression; observational; assessment; motion capture

Outcome Measures

Primary Outcomes (1)

• change in PASS-MS kinematic parameter Short Maximum Speed Walk - Speed (SMSW-MaxS)

  walking speed calculated from short distance walking in the SMSW task

  change from baseline value at 2 years

Interventions

PASS-MS DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to include and follow-up 100 patients with a diagnosis of MS according to revised McDonald criteria including relapsing-remitting and progressive disease courses. The design as a single-center study implied that broad inclusion criteria (RRMS, SPMS, PPMS) should be used in order to obtain robust results. We therefore chose not to limit recruitment to progressive MS, which would have required a multi-center study. Still, we conceive the main results of our study - sensitivity and responsiveness - to be conferrable to progressive MS (yet not the progression rates). We restrict inclusion to those able to walk at least short distance with unilateral assistance according to the testing requirements of the primary outcome. We further include patients with any intervention for MS or other morbidity as long as this is not considered to affect balance or locomotor function. Type of MS treatment and comorbidities are documented at baseline and follow-up.

You may qualify if:

• diagnosis of multiple sclerosis (relapsing-remitting, secondary or primary chronic progressive)
• ability to perform PASS-MS short walking test (max. of 5 m distance) with no or only unilateral assistance (EDSS \<6.5)
• written consent

You may not qualify if:

• Inability to understand/ follow test instructions for any reason
• Other cause of locomotor or balance dysfunction than MS

Sponsors & Collaborators

• Friedemann Paul: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Experimental and Clinical Research Center, Studienambulanz Neuroimmunologie am Standort NCRC, Campus Mitte,Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• Ellinghaus CA, Rohling HM, Dorsch EM, Sperber PS, Arsenova R, Buenrostro GS, Rekers S, Usnich T, Schindler P, Kroneberg D, Bellmann-Strobl J, Oertel FC, Brandt AU, Weygandt M, Paul F, Piper SK, Schmitz-Hubsch T. Anchor-based evaluation of digital motor biomarkers from a 2-year observation in 100 patients with multiple sclerosis. J Neurol. 2025 Dec 4;273(1):4. doi: 10.1007/s00415-025-13541-y.

  PMID: 41342942 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis; Disease Progression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Friedemann Paul

  Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Direktor ECRC, Leiter AG Klinische Neuroimmunologie

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: August 6, 2021
• Study Start: February 20, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)