NCT03111394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

4.6 years

First QC Date

March 15, 2017

Last Update Submit

November 24, 2021

Conditions

Keywords

MS23andMeMRIGenome-wide association studies

Outcome Measures

Primary Outcomes (1)

  • Participants willing to provide genetic and MRI data via myMS

    Proportion of participants with both genetic and MRI data available

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with a diagnosis of Multiple Sclerosis.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aimslab@Usc.Edu

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples are collected for DNA analysis

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Daniel Pelletier, M.D.

    Keck School of Medicine of USC, University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology; Vice Chair, Clinical Research, Department of Neurology; Division Chief, Neuro-Immunology and USC Multiple Sclerosis Center

Study Record Dates

First Submitted

March 15, 2017

First Posted

April 12, 2017

Study Start

April 17, 2017

Primary Completion

November 25, 2021

Study Completion

November 25, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations