Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501950
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-20
Brief Title:
Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
360PMS
Brief Summary:
This observational study wants to examine the disease progression independent of relapses in patients with Multiple Sclerosis MS that are treated with monoclonal antibodies Participants will be clinically examined every 6 months and optionally receive a magnetic resonance imaging MRI every 12 months The investigators will also take blood for blood biomarker tests with each clinical examination Optionally digital data can be continuously collected via smartphone and smartwatch
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
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
Detailed Description:
The goal of this observational prospective observational multicenter proof of concept study is to identify silent disease progression in people with multiple sclerosis MS that are treated with monoclonal antibodies
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 70 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
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 70 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None