NCT04599023

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

October 16, 2020

Last Update Submit

March 7, 2023

Conditions

Multiple SclerosisClinically Isolated Syndrome

Keywords

MSCISMSFCContrast Sensitivity TestWalking Speed Test25 foot walkManual Dexterity TestProcessing Speed Testself-administratingmedical device

Outcome Measures

Primary Outcomes (7)

  • Percentage of patients who complete all modules

    Percentage of patients who complete all modules (out of those who initiate testing) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Percentage of patients who complete each module

    Percentage of patients who complete each module (out of those who initiate each module) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Percentage of patients who skip modules

    Percentage of patients who skip modules (out of those who initiate testing) will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Time to complete the MSPT

    Time to complete the MSPT will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Time to complete the individual MSPT modules

    Time to complete the individual MSPT modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Frequency of reasons for not completing test modules

    Frequency of reasons for not completing test modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

  • Frequency distribution of demographic characteristics of patients who fail to complete specific MSPT modules

    Frequency distribution of demographic characteristics (as captured in the MyHealth module) of patients who fail to complete specific MSPT modules will be measured to evaluate the feasibility of the MSPT in a clinical care setting when used by MS patients.

    2 years

Secondary Outcomes (5)

  • Net promoter score based on satisfaction questionnaires

    2 years

  • Net promoter score based on patient questionnaire

    2 years

  • Net promoter score based on treating physician and administrator questionnaire for improved monitoring of MS disease progression

    2 years

  • Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience

    2 years

  • Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time

    2 years

Study Arms (1)

MS patients including CIS

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.

Device: MSPT

Interventions

MSPTDEVICE

The MS Performance Test (MSPT) software tool and accompanied hardware is an iPad®-based assessment tool, developed via collaboration between Biogen and the Cleveland Clinic Mellen Center, and designed to objectively quantify the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders.These assessment modules of the MSPT are self-administered by MS patients at the point of care and incorporate and expand upon previously validated measures of the MSFC.

MS patients including CIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern, Ambulantes Neurozentrum

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Robert Hoepner, PD Dr. med.

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

October 16, 2020

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)