- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993274
Sensitivity of Motor Assessment in MS - a Prospective Cohort Study (MOTOSENS)
Sensitivity of Quantitative Motor Performance Measures in Multiple Sclerosis - a Prospective Cohort Study Over Two Years Using Microsoft Kinect
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed as a prospective observational (non-interventional) single-center study performed at one center, Charité - Universitätsmedizin Berlin.
This study converges with prospective observational studies performed at our center. These studies started in 2011 with the objective to define determinants of progression in neuroimmunological disorders (CIS, MS, NMO).
The variables collected for this study were defined according to the study objective and comprise different markers of motor/mobility function, cognitive and affective function, fatigue and health-related quality of life. The primary outcome is a VPC-based assessment of locomotor function (PASS-MS SMSW-MaxS) as the diagnostic test under study. Secondary outcomes serve to cross-validate progression rates or as benchmarks of clinical progression to determine clinical relevance of change. Further, possible effects of cognitive and affective function on the primary outcome can be explored which is of high relevance for the interpretation of changes in the population of MS.
All assessments are performed at inclusion and after 12and 24 months.
Primary outcome:
PASS-MS kinematic parameters with Short Maximum Speed Walk - Speed (SMSW-MaxS) as primary outcome
Secondary outcomes:
- Clinical Examination
- Other kinematic parameters derived from PASS-MS
- Clinical Rating with EDSS and Multiple Sclerosis Functional Composite (MSFC) consisting of tests of walking capacity (T25FW), hand dexterity (9HPT), cognitive processing speed (SDMT) and visual acuity (Sloan charts)
- Cognitive testing (BRB-N)
- Patient-reported outcomes on global impression of change, MS-related impairment in walking (MSWS-12), hand function, occurrence of fatigue (FSMC), depressive symptoms (BDI-II) and health-related quality of life by MS-specific questionnaire (HAQUAMS)
A change in T25FW speed of at least 20% was found to be clinically meaningful for MS patients (Hobart 2013). In a previous study the investigators found SMSW average walking speed was slower in MS patients (1.6 ± 0.3 m/sec) than in HC (1.8 ± 0.4 m/sec) (Behrens 2014). Therefore, a similar average walking speed was assumed for the population under study at baseline (1.6 m/sec) and a decrease of 0.3 m/sec (corresponding to approximately 20%) as clinically meaningful. Moreover, based on previous reports, investigators assume a standard deviation in the changes of SMSW-MaxS of 0.4 m/sec (Behrens 2014). This results in an expected effect size of 0.75 for the change in SMSW-MaxS between baseline and 24 months follow-up in those with clinically confirmed disability progression. A sample size of N=16 patients will have a power of 80% to detect an effect size of 0.75 with a two-sided significance level of 0.05 and a t-test for dependent samples (nQuery Advisor 7.0).
Sample size estimation considered previous evidence on the proportion of patients who will show clinically confirmed disability progression throughout the observation period based on an EDSS change defined as 1 step increase in EDSS ≤ 5.5 and 0.5 step in EDSS > 5.5 within 24 months. Cutter et al. (1999) reported that 10% of their patients showed EDSS confirmed sustained change within 3 months and 40% showed a change to baseline in 1 year reported in MSFC, which also incorporates the T25FW. The investigators assume that at least 20 % of patients showing a confirmed sustained change in EDSS according to above definition within 24months to be a realistic scenario.
When considering an overall dropout rate of 10-20% (lost to follow-up), this would result in N=16 complete datasets when overall N=100 patients are included.
Patients should not have had an acute relapse up to 3 months before follow-up visit (12 and 24 months). To avoid dropout due to acute relapse the follow-up visit is extended to up to 3 months in case of acute relapse.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- Experimental and Clinical Research Center, Studienambulanz Neuroimmunologie am Standort NCRC, Campus Mitte,Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to understand/ follow test instructions for any reason
- Other cause of locomotor or balance dysfunction than MS
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in PASS-MS kinematic parameter Short Maximum Speed Walk - Speed (SMSW-MaxS)
Time Frame: change from baseline value at 2 years
|
walking speed calculated from short distance walking in the SMSW task
|
change from baseline value at 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Friedemann Paul, Experimental and Clinical Research Center, Charité - Universitätsmedizin Berlin, Germany
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
Other Study ID Numbers
- EA1/240/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis, Chronic Progressive
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Atara BiotherapeuticsTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States, Australia, Canada
-
University Hospital, AntwerpHasselt University; University Hospital, Ghent; AZ Sint-Jan AV; National MS Center... and other collaboratorsRecruitingMultiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary-progressive Multiple SclerosisBelgium
-
Rebecca SpainCompletedComparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisProgressive Multiple Sclerosis | Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Johns Hopkins UniversityCompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkUniversity of Copenhagen; Biogen; Copenhagen University Hospital, Hvidovre; Signifikans...CompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
Clinical Trials on PASS-MS
-
Medicrea InternationalActive, not recruitingSpinal Deformity | Spinal Degeneration | Thoracolumbar Disc Degeneration | Thoracolumbar SpondylolisthesisFrance
-
Medical University of South CarolinaBoston Scientific CorporationRecruitingSubcutaneous ICD | Myopotential InterferenceUnited States
-
Boston Children's HospitalPatient-Centered Outcomes Research Institute; Pediatric Research in Inpatient...RecruitingCommunicationUnited States
-
University of Illinois at ChicagoCongressionally Directed Medical Research ProgramsRecruitingMultiple Sclerosis | Major Depressive DisorderUnited States
-
Medicrea InternationalCompletedSpinal Stenosis | Spinal Fractures | Spondylolisthesis | Spinal Neoplasms | Intervertebral Disc DiseaseFrance
-
Huazhong University of Science and TechnologyUnknown
-
University of British ColumbiaWithdrawn
-
Zimmer BiometCompletedRotator Cuff Tear | Anterior Cruciate Ligament InjuryUnited States