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Study of myMS in Participants With a Diagnosis of Multiple Sclerosis

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT03111394
Collaborator
(none)
200
Enrollment
1
Location
55.3
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Apr 17, 2017
    Actual Primary Completion Date :
    Nov 25, 2021
    Actual Study Completion Date :
    Nov 25, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Participants willing to provide genetic and MRI data via myMS [12 months]

      Proportion of participants with both genetic and MRI data available

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aimslab@Usc.Edu Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    • Principal Investigator: Daniel Pelletier, M.D., Keck School of Medicine of USC, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Pelletier, Professor of Neurology; Vice Chair, Clinical Research, Department of Neurology; Division Chief, Neuro-Immunology and USC Multiple Sclerosis Center, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03111394
    Other Study ID Numbers:
    • HS-16-00579
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Nov 26, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Daniel Pelletier, Professor of Neurology; Vice Chair, Clinical Research, Department of Neurology; Division Chief, Neuro-Immunology and USC Multiple Sclerosis Center, University of Southern California
    MS
    23andMe
    MRI
    Genome-wide association studies
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Nov 26, 2021