Remote monitoring for adults with myasthenia gravis to see if it works

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the feasibility and reliability of a remote monitoring program for adults with acquired autoimmune myasthenia gravis. Participants will use technology to track physiological and activity-related signals, complemented by telemedicine evaluations. The goal is to determine whether this approach can reliably identify MG worsening and support timely treatment changes, potentially avoiding hospitalization. Compliance with the monitoring protocol and the practicality of the telemedicine workflow will be assessed. No intervention beyond monitoring is specified in the available description.

Why it matters

Who can join: the full rules

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 -

Where it's running

• The George Washington University
  Washington D.C., District of Columbia, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.