Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 1:30 AM
Study NCT ID:
NCT03111394
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of myMS in Participants With a Diagnosis of Multiple Sclerosis
Sponsor:
University of Southern California
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: