MSPT Device Usability Study

Multiple Sclerosis Clinical Trial

— MSPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664324
• Other study ID #: 888MS003
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: May 2, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland
United States	Research Site	Cleveland	Ohio
United States	Research Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study participants successfully completing all modules of the MSPT device	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)	No
Primary	Percent (%) of study participants successfully completing all modules of the MSPT device		Through study duration (3-4 hours)	No
Secondary	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	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)	No
Secondary	Percent (%) of study participants who reported being satisfied or completely satisfied with using MSPT device	MSPT satisfaction survey is a 1 item paper-based questionnaire to measure participant satisfaction with the MSPT device.	Through study duration (3-4 hours)	No
Secondary	Difference of manual timed versus Bluetooth timed in Walking Speed Test (WST) as assessed by Timed 25 foot walk	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)	No
Secondary	The percent (%) of study participants who have usability issues with Bluetooth remote due to use of an assistive device(s)		Through study duration (3-4 hours)	No
Secondary	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		Through study duration (3-4 hours)	No
Secondary	Between-site differences in percent (%) of study participants who select satisfied/completely satisfied on MSPT Satisfaction Survey		Through study duration (3-4 hours)	No