Clinical trial NCT03111394: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: MS
23andMe
MRI
Genome-wide association studies
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a diagnosis of 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.

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.

Primary outcomes:
measure: Participants willing to provide genetic and MRI data via myMS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Aimslab@Usc.Edu
state: California
Study officials:
affiliation: Keck School of Medicine of USC, University of Southern California
name: Daniel Pelletier, M.D.
role: PRINCIPAL_INVESTIGATOR
References: