💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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 -
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