Study of myMS in Participants With a Diagnosis of Multiple Sclerosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | April 17, 2017 |
| End Date: | December 2020 |
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
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.
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.
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.
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.
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.
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