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Study of myMS in Participants With a Diagnosis of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03111394
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Pelletier, University of Southern California

Study Description
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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
Multiple Sclerosis

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
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Study Type : Observational
Estimated 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 : April 17, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Participants willing to provide genetic and MRI data via myMS [ Time Frame: 12 months ]
    Proportion of participants with both genetic and MRI data available


Biospecimen Retention:   Samples With DNA
Saliva samples are collected for DNA analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with a diagnosis of Multiple Sclerosis.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111394


Locations
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United States, California
Aimslab@Usc.Edu
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Daniel Pelletier, M.D. Keck School of Medicine of USC, University of Southern California
More Information
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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     History of Changes
Other Study ID Numbers: HS-16-00579
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Participants will have the option to opt in or out for researchers to be able to share individual participant data (IPD) with researchers outside of USC.
Keywords provided by Daniel Pelletier, University of Southern California:
MS
23andMe
MRI
Genome-wide association studies
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases