Multiple SclerosisMSPTNCT04599023
Assessing the Feasibility of the MSPT Device in Routine Clinical Practice in the Swiss Healthcare System
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Clinically Isolated Syndrome
- What is being tested?
- MSPT
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2020to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Feasibility of the Multiple Sclerosis Performance Test (MSPT) Device in Routine Clinical Practice in the Swiss Healthcare System
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.
Read the 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 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.
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Being tested
- MSPT
- Keywords
- MS, CIS, MSFC, Contrast Sensitivity Test, Walking Speed Test, 25 foot walk, Manual Dexterity Test, Processing Speed Test, self-administrating, medical device
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MSPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Secondary outcomes (5)
Net promoter score based on satisfaction questionnaires
Net promoter score based on satisfaction questionnaires conducted with patients to probe about experience interfacing the MSPT
Measured: 2 years
Net promoter score based on patient questionnaire
Net promoter score based on patient questionnaire related to perceived benefit of the MSPT for improved monitoring of MS disease progression
Measured: 2 years
Net promoter score based on treating physician and administrator questionnaire for improved monitoring of MS disease progression
Net promoter score based on treating physician and administrator questionnaire related to perceived benefit of the MSPT for improved monitoring of MS disease progression
Measured: 2 years
Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience
Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience interfacing the MSPT
Measured: 2 years
Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time
Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time (e.g., newly diagnosed, untreated RRMS, patients with cognitive impairment, patients with cognitive impairment but only mild physical disability, patients of different area of origin)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start16 Oct 2020
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Why it stopped: Decision of company to no longer develop the device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Robert Hoepner, PD Dr. med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599023
- Sponsor's protocol ID
- CH-MSG-11563
- Acronym
- MSPT
- Status last verified
- Mar 2023
- First submitted
- 16 Oct 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of the Multiple Sclerosis Performance Test (MSPT) Device in Routine Clinical Practice in the Swiss Healthcare System
- ClinicalTrials.gov ID
- NCT04599023
- Acronym / sponsor ID
- MSPT / CH-MSG-11563
- Conditions
- Multiple Sclerosis, Clinically Isolated Syndrome
- Keywords
- MS, CIS, MSFC, Contrast Sensitivity Test, Walking Speed Test, 25 foot walk, Manual Dexterity Test, Processing Speed Test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision of company to no longer develop the device.
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS patients including CIS | – | Device: MSPTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of MS, including Clinically Isolated Syndrome (CIS)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSPTThe 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. | Device | MS patients including CIS |
Primary outcome
Percentage of patients who complete all modules
Time frame: 2 years
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.
Percentage of patients who complete each module
Time frame: 2 years
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.
Percentage of patients who skip modules
Time frame: 2 years
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.
Time to complete the MSPT
Time frame: 2 years
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.
Time to complete the individual MSPT modules
Time frame: 2 years
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.
Frequency of reasons for not completing test modules
Time frame: 2 years
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.
Frequency distribution of demographic characteristics of patients who fail to complete specific MSPT modules
Time frame: 2 years
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.
5 secondary outcomes
Net promoter score based on satisfaction questionnaires
Time frame: 2 years
Net promoter score based on patient questionnaire
Time frame: 2 years
Net promoter score based on treating physician and administrator questionnaire for improved monitoring of MS disease progression
Time frame: 2 years
Net promoter score based on satisfaction questionnaires conducted with treating physicians and the MSPT administrator to probe about experience
Time frame: 2 years
Change in MSPT outcomes in patient subgroups of interest at baseline and at each visit over time
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Decision of company to no longer develop the device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hoepner, PD Dr. med. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Clinically Isolated Syndrome, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision of company to no longer develop the device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who complete all modules (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.