Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599023
Status:
TERMINATED
Last Update Posted:
2023-03-10
First Post:
2020-10-16
Brief Title:
Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Assessing the Feasibility of the Multiple Sclerosis Performance Test MSPT Device in Routine Clinical Practice in the Swiss Healthcare System
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision of company to no longer develop the device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSPT
Brief Summary:
The Multiple Sclerosis Functional Composite MSFC a reliable and well-validated instrument was developed as a multidimensional quantitative measure of neurologic disability in MS However the traditional form of the MSFC has various limitations including the need for MS patients to be assessed in a clinical setting by trained technicians which requires additional human resources and time in a clinical routine practice setting Furthermore storage of MSFC data for longitudinal comparison is difficult and time consuming The MS Performance Test MSPT software tool is designed to objectively quantify the major motor visual and cognitive function data and quality of life outcomes associated with MS and related disorders
This is a single center observational study that will examine the use of the MSPT in a real world setting Study enrollment will occur at one center in Switzerland
This is a single center observational study that will examine the use of the MSPT in a real world setting Study enrollment will occur at one center in Switzerland
Detailed Description:
Study participation will be offered to MS patients either on day of clinic visit Patient screening consent discussion and MSPT test completion is estimated to take approximately an hour prior to the appointment with the treating physician Participants begin with an instructional overview which acquaints them with all elements of the MSPT The tests will be performed in the same order and if a study participant elects to discontinue testing or skip a module they will be asked to indicate the reasons on the screen Each module has accompanying instructions
Upon completion of testing at first and last study visit patients research nursecoordinator and treating physician will be asked to fill in a short satisfaction questionnaire related to the functionality of the MSPT
HCPs will have the ability to view de-identified longitudinal MSPT outcomes for each patient on the MSPT tool
De-identified data abstracted from each site will be stored in a cloud-based data repository Access to the MSPT Cloud and data therein is restricted to the healthcare institution using the registered MSPT tool The site will periodically send de-identified and encrypted aggregate data to Biogen
Upon completion of testing at first and last study visit patients research nursecoordinator and treating physician will be asked to fill in a short satisfaction questionnaire related to the functionality of the MSPT
HCPs will have the ability to view de-identified longitudinal MSPT outcomes for each patient on the MSPT tool
De-identified data abstracted from each site will be stored in a cloud-based data repository Access to the MSPT Cloud and data therein is restricted to the healthcare institution using the registered MSPT tool The site will periodically send de-identified and encrypted aggregate data to Biogen
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?:
False
Is an FDA AA801 Violation?:
None