Purpose

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fluctuating weakness, which can worsen suddenly without a clear predictor. The hypothesis is that continuous monitoring of key aspects of patient physiology and activity coupled to rigorous telemedicine-performed examination has the potential to detect MG worsening which requires change in treatment with the benefit of avoiding need for hospitalization or emergent therapy. This study is to evaluate the reliability of the technology and patient compliance to the monitoring program

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Subject 1. Has the capacity to understand and sign an informed consent form 2. ≥18 years old 3. Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single fiber electromyography (EMG) or positive edrophonium test 4. Subject has been previously evaluated in a face-to-face clinical encounter at participating study site or referral site within the prior 3 years 5. Primary language is English, or equivalent level of English language fluency 6. Required disease severity range previously judged by the Investigator. MGFA class 1-4a within 3 years of diagnosis without other chronic medical conditions, which compromise participation. 7. Having MG-ADL score above 2 upon entrance to study 8. Patients considered by study PI not to require hospitalization at time of entrance 9. The patient has internet capability and a smart phone compatible with the apps required by the study.

Exclusion Criteria

Disease Specific Exclusion Criteria 1. Inability to comply with study protocol for monitoring 2. Current MGFA Severity Class IVb or V, or patients in remission with MGFA Class 0 3. Any significant medical/psychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance 4. Any disorder that could limit ability to assess myasthenia gravis specific deficits (not including planned or recent thymectomy) 5. Pregnancy, based on the evaluator's judgment, if the subject is deemed not safe to undergo evaluation or comply with study visit requirements. 6. Lack of effective internet connection or ability to use study telemedicine station and monitors 7. Home environment prevents use of study equipment 8. Likelihood of leaving DC, Maryland, or Virginia area in year after initiation of study 9. Subject is already participating in a research study -

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

The George Washington University
Washington D.C., District of Columbia 20037
Contact:
Gulsen Oztosun, M.D.
202-677-6109
gulsen.oztosun@gwu.edu

More Details

Status
Recruiting
Sponsor
George Washington University

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.