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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

Tracking Information
First Submitted Date March 15, 2017
First Posted Date April 12, 2017
Last Update Posted Date April 1, 2019
Actual Study Start Date April 17, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 6, 2017)
Participants willing to provide genetic and MRI data via myMS [ Time Frame: 12 months ]
Proportion of participants with both genetic and MRI data available
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03111394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of myMS in Participants With a Diagnosis of Multiple Sclerosis
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Saliva samples are collected for DNA analysis
Sampling Method Probability Sample
Study Population Participants with a diagnosis of Multiple Sclerosis.
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 6, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03111394
Other Study ID Numbers HS-16-00579
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Daniel Pelletier, University of Southern California
Study Sponsor University of Southern California
Collaborators Not Provided
Investigators
Principal Investigator: Daniel Pelletier, M.D. Keck School of Medicine of USC, University of Southern California
PRS Account University of Southern California
Verification Date March 2019