Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Treatments: Device: MSPT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04599023

CH-MSG-11563

Details and patient eligibility

About

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.

Full 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 nurse/coordinator 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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Diagnosis of MS, including Clinically Isolated Syndrome (CIS)
• Ability to understand the audio and visual instructions for the test modules
• Visual function, based on the investigator's clinical judgement, that does not preclude an ability to interact with the MSPT.

Exclusion criteria

• Unable or unwilling to provide informed consent.
• Patients under 18 years of age will be excluded.
• Other unspecified reasons that, in the opinion of the Sponsor-Investigator, make the patient unsuitable for participation in the demonstration project. A patient only needs to complete the assessments deemed appropriate by the Sponsor-Investigator.

Trial design

182 participants in 1 patient group

MS patients including CIS

Description:

Patients with a diagnosis of MS, including Clinically Isolated Syndrome (CIS), who have the ability to understand the audio and visual instructions for the MSPT modules and whose visual function that does not preclude an ability to see the screen of the MSPT tool.

Treatment:

Device: MSPT