Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
NCT ID: NCT06501950
Last Updated: 2024-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
77 participants
OBSERVATIONAL
2024-06-20
2027-12-31
Brief Summary
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With this information the study will compare the results from clinical, digital, radiological, and blood-based tests with the disease progression the participants report themselves. This study aims to investigate what percentage auf patients with MS under antibody treatment experience a slow progression of the disease.
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Detailed Description
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Progression independent of relapse activity (PIRA) refers to disability progression unrelated to relapses. Treatment with disease-modifying agent shifts the primary cause of disability towards PIRA, likely due to the prevention of relapses during therapy. In order to promptly identify these patients in the future, newer biomarkers are needed that can detect disease activity more sensitively. Digital health technologies (DHTs), such as connected wearables, offer the capability of continuously collecting real-life data. As they can capture movement patterns, sleep behavior, and cognition, DHTs can document silent disease progression in MS patients and have the potential to enhance our understanding of disease activity.
The goal of the 360 PMS (progressive Multiple Sclerosis) study is to evaluate various widely available smartwatch-derived digital metrics and blood-based analyses as well as imaging tools for monitoring silent disease activity in MS patients at two study centres. Patients with relapsing remitting or primary progressive MS that are treated with monoclonal antibodies and do not have an Expanded Disability Status Scale (EDSS) of more than 7,0 will be included in this study.
Clinical evaluations will be conducted every 6 months, as well as blood-based measurements that include serum neurofilament-light-chain (sNfL), glial fibrillary acidic protein (GFAP) and proteomic data. Data captured by smartwatches (Withings Scanwatch) include activity-related data (step count, minutes in certain intensity levels), basic cardiovascular measurements such as heart rate, and sleep-related data (total time asleep, sleep efficiency and quality etc.). Additionally, disease progression can be optionally evaluated by monitoring fine motor skills while typing on the smartphone by a smartphone application (Neurokeys).
The study will initially start at the core centre at the University Clinic Düsseldorf and plans to enrol further sites in the months following initiation. Further centers might not include optical coherence tomography (OCT) or MRI measurements. At the core facility additional examinations will be conducted: Structural MRI examinations will be conducted at baseline and in month 12 and 24. OCT measurements will examine retinal morphology and be conducted every 6 months.
The investigators will attempt to closely analyze MS patients under treatment with monoclonal antibodies with these methods. Data will be collected for a 24-month prospective period.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Core centre
Persons that will be included by the core centre will be examined every 6 months by clinical testing, blood tests, and optical coherence tomography. A MRI will be conducted every 12 month. Additional digital monitoring using a smartwatch and smartphone ist optional.
No interventions assigned to this group
Other study centre
Persons that will be included by the other study centre will be examined every 6 months by clinical testing and blood tests. Additional digital monitoring using a smartwatch and smartphone ist optional.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Current treatment with monoclonal antibodies (including Natalizumab, Ofatumumab, Ocrelizumab) according to SmPC
* EDSS ≤7.0
Exclusion Criteria
* Any comorbidity resulting in an impairment to understand or successfully complete the study such as (but not restricted to) psychiatric comorbidities or dementia. Decision will be made at investigators discretion.
* Additional immunosuppression except of above mentioned monoclonal antibodies
* Pregnancy
18 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Dr. med. Marc Günter Pawlitzki
Study coordinator / PI
Principal Investigators
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Marc Günter Pawlitzki, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Heinrich-Heine University, Duesseldorf
Locations
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University Hospital Düsseldorf, Department of Neurology
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.
Masanneck L, Voth J, Huntemann N, Ozturk M, Schroeter CB, Ruck T, Meuth SG, Pawlitzki M. Introducing electronic monitoring of disease activity in patients with chronic inflammatory demyelinating polyneuropathy (EMDA CIDP): trial protocol of a proof of concept study. Neurol Res Pract. 2023 Aug 24;5(1):39. doi: 10.1186/s42466-023-00267-3.
Other Identifiers
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360PMS_1.0
Identifier Type: -
Identifier Source: org_study_id
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