Study of myMS in Participants With a Diagnosis of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Pilot Study Evaluating the Feasibility of A Mobile Application to Collect Clinical, Magnetic Resonance Imaging Information and Genetic Data in Participants With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111394
• Other study ID #: HS-16-00579
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: November 25, 2021

Study information

• Verified date: November 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a pilot study looking at the feasibility of a mobile application (app) to collect data from active tasks (questionnaires, 6Mapp™, COGapp™, VISapp™), clinical magnetic resonance imaging information and conduct genome-wide association studies in subjects with multiple sclerosis. Participants will be self-referred to this study from different sources; patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.

Description:

This is a pilot study evaluating the feasibility of a mobile application "myMS™" to collect active clinical tasks (questionnaires, 6Mapp™, COGapp™, VISapp™), magnetic resonance imaging information and conduct genome-wide association studies in subjects with multiple sclerosis. Participants will be self-referred to this study from different sources; patient advocacy groups, social media tools, clinicaltrials.gov, and flyers.

Specific aims of this pilot study are:

1. To determine the feasibility and work flow in prospectively collecting surveys, clinical tasks, magnetic resonance imaging (MRI) information for up to 200 self-referred adult MS participants, using mobile app myMS™.

2. To determine the feasibility of using interface between myMS™ and 23andMe® DNA Kits and 23andme password protected mobile app platform (GSR Dashboard) in collecting one biological (saliva) sample and distributing the genetic result (using commercially available results only, distributed by 23andme®), for up to 200 self-referred adult MS participants. This aim is for testing the system interface only. 23andme® has their own independent consent form and IRB coverage for their commercial product.

3. To estimate the percentage of registered participants that will meet eligibility criteria for MS.

4. To estimate the percentage of participants that a) complete all clinical tasks; b) complete all surveys; c) provide genetic information; and d) provide MRI scans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females participants with access to an iPhone 5 and above.

• Participants willing to provide electronic consent.

• Age 18 and above.

• A diagnosis of MS (Polman, 2010), with dissemination in time and space. CIS participants will be included if they fulfil 3 of the 4 MRI criteria for dissemination in space as per Polman et al. 2010.

• EDSS of between 0 and 8.0

Exclusion Criteria:

• Under 18 years of age

• Participants who do not consent to participate.

• Participants participating in ongoing MS clinical trials with non-approved drugs.

• Any concurrent illness, disability or clinically significant abnormality (including laboratory tests) that may prevent the subject from safely completing the assessments required by the protocol.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Aimslab@Usc.Edu	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants willing to provide genetic and MRI data via myMS	Proportion of participants with both genetic and MRI data available	12 months