Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309173
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-06
Brief Title:
Development of Digital Biomarkers in Multiple Sclerosis Validation Study 2
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Development of Digital Biomarkers in Multiple Sclerosis Validation Study 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
DreaMS_VS2
Brief Summary:
Multiple sclerosis MS is a chronic inflammatory disease of the central nervous system CNS Diagnosis is established by clinical assessment of persons with MS PwMS in combination with imaging and body fluid assessments Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments
The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely in real-world settings with minimal disruption of patients life
Using the investigators self developed dreaMS software program the investigators previously identified digital biomarkers DB that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical imaging or body fluid assessments
This international observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care research and regulatory decisions Beyond this the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies including pragmatic trials promoting new long-term international academic collaborations
The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely in real-world settings with minimal disruption of patients life
Using the investigators self developed dreaMS software program the investigators previously identified digital biomarkers DB that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical imaging or body fluid assessments
This international observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care research and regulatory decisions Beyond this the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies including pragmatic trials promoting new long-term international academic collaborations
Detailed Description:
Multiple sclerosis MS is a chronic inflammatory disease of the central nervous system Focal demyelination and diffuse neurodegeneration in the gray and white matter of the brain and spinal cord lead to decreased physical and cognitive functioning and disability
Diagnosis is established by clinical assessment of persons with MS PwMS including taking their history and neurologic examination in combination with imaging and body fluid assessments Treatment decisions in MS are based on continuous monitoring of MS disease activity and progression through clinical and imaging assessments while the role of body fluid assessments is not yet universally established The predictive and prognostic value of these currently used assessments to individualize treatment decisions is still very limited New and more reliable measures are needed especially indicators of disease progression which allow to personalize therapies and care
With the digitization of healthcare new opportunities are emerging to provide quasi-continuous and granular health status measurements as digital measures Such digital measures may allow to monitor MS disease activity and progression more informatively than the only episodical traditional assessments Digital health technologies allow to remotely capture dynamic fluctuating functions and symptoms in real world settings with minimal disruption of patients life and usual care
The investigators developed the dreaMS software program that includes app-based interactions with the patients patient-reported information via surveys and continuous monitoring through sensors In a previous study NCT04413032 which evaluated the feasibility and acceptance of using our dreaMS software program we identified digital biomarkers DB that are relevant for PwMS These DB are evaluated and validated in an ongoing study including a larger population of PwMS in Switzerland NCT05009160
This international observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care research and regulatory decisions Beyond this the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies including pragmatic trials promoting new long-term international academic collaborations
Diagnosis is established by clinical assessment of persons with MS PwMS including taking their history and neurologic examination in combination with imaging and body fluid assessments Treatment decisions in MS are based on continuous monitoring of MS disease activity and progression through clinical and imaging assessments while the role of body fluid assessments is not yet universally established The predictive and prognostic value of these currently used assessments to individualize treatment decisions is still very limited New and more reliable measures are needed especially indicators of disease progression which allow to personalize therapies and care
With the digitization of healthcare new opportunities are emerging to provide quasi-continuous and granular health status measurements as digital measures Such digital measures may allow to monitor MS disease activity and progression more informatively than the only episodical traditional assessments Digital health technologies allow to remotely capture dynamic fluctuating functions and symptoms in real world settings with minimal disruption of patients life and usual care
The investigators developed the dreaMS software program that includes app-based interactions with the patients patient-reported information via surveys and continuous monitoring through sensors In a previous study NCT04413032 which evaluated the feasibility and acceptance of using our dreaMS software program we identified digital biomarkers DB that are relevant for PwMS These DB are evaluated and validated in an ongoing study including a larger population of PwMS in Switzerland NCT05009160
This international observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care research and regulatory decisions Beyond this the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies including pragmatic trials promoting new long-term international academic collaborations
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