MSPT Device Usability Study (MSPT)

May 2, 2016 updated by: Biogen

The Multiple Sclerosis Performance Test (MSPT) Device for Functional Assessment of Multiple Sclerosis (MS) Patients

The primary objective of this feasibility study is to evaluate the functionality (e.g., as defined by the primary endpoints) of the fully integrated Multiple Sclerosis Performance Test (MSPT) device, when used by unsupervised participants with MS, or related conditions, with a broad range of disability, in multi-clinical-care environments. Secondary objectives include: Participant perception of usability of device; Participant satisfaction with the device; Ascertain the impact of different clinical environments on device usability; Ascertain impact of assistive devices in usability of device; Ascertain functionality of Bluetooth remote as compared with manual timing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study does not involve evaluation(s) of the clinical efficacy of the MSPT device or the efficacy of MS therapies. This feasibility study is examining the usability of the fully integrated MSPT device. Study participants will be enrolled for same-day testing.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Multiple sclerosis patients or patients with related conditions in a clinical care setting.

Description

Key Inclusion Criteria:

  • Diagnosis of MS, or related conditions, such as: Clinically Isolated Syndrome (CIS), Neuromyelitis Optica (NMO), and Transverse Myelitis (TM)
  • Literacy of written English language as displayed on software tool
  • Ability to understand and comprehend software tool from the audio and visual instructions provided in English

Key Exclusion Criteria:

  • Study participants, who in the opinion of the Investigator, have vision impairment that precludes their ability to see the iPad Air2® screen/MSPT device.
  • Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis of Tourette's syndrome), head trauma with significant loss of consciousness (>30 minutes), cerebral palsy, dementia (including mild cognitive impairment and Alzheimer's disease), chronic meningitis, Parkinson's disease, and Huntington's disease.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of study participants successfully completing all modules of the MSPT device
Time Frame: Through study duration (3-4 hours)
The MSPT software tool builds upon previously validated measures comprising the Multiple Sclerosis Functional Composite (MSFC) that represents a comprehensive functional assessment of MS participants that include: MyHealth: MS -Patient demographic, health and medication information; NeuroQoL - Neurological Quality of Life test -Participant reported; PST Processing Speed Test- Measures mental processing speed; Contrast Sensitivity Test (CST)- 50cm vision test; MDT Manual Dexterity Test- 9 hole peg test; WST Walking Speed Test - Timed 25 foot walk
Through study duration (3-4 hours)
Percent (%) of study participants successfully completing all modules of the MSPT device
Time Frame: Through study duration (3-4 hours)
Through study duration (3-4 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6-9) on appropriate questions on the MSPT Usability Survey
Time Frame: Through study duration (3-4 hours)
MSPT usability survey is a 10 item paper-based questionnaire to measure participant perception of the usability of the device. A study participant will meet the usability secondary endpoints if usability (agree/strongly agree or disagree/strongly disagree, as appropriate) is selected for 6 or more survey questions.
Through study duration (3-4 hours)
Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device
Time Frame: Through study duration (3-4 hours)
MSPT satisfaction survey is a 1 item paper-based questionnaire to measure participant satisfaction with the MSPT device.
Through study duration (3-4 hours)
Difference of manual timed versus Bluetooth timed in Walking Speed Test (WST) as assessed by Timed 25 foot walk
Time Frame: Through study duration (3-4 hours)
T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet.
Through study duration (3-4 hours)
The percent (%) of study participants who have usability issues with Bluetooth remote due to use of an assistive device(s)
Time Frame: Through study duration (3-4 hours)
Through study duration (3-4 hours)
Between-site differences in percent (%) of study participants who select agree/strongly agree (questions 1 to 5) or disagree/ strongly disagree (questions 6 to 9) on appropriate questions on the MSPT Usability Survey
Time Frame: Through study duration (3-4 hours)
Through study duration (3-4 hours)
Between-site differences in percent (%) of study participants who select satisfied/completely satisfied on MSPT Satisfaction Survey
Time Frame: Through study duration (3-4 hours)
Through study duration (3-4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 888MS003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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