Recruiting

Observational Study

Sponsor:

George Washington University

Code:

NCT07787247

Conditions

Myasthenia Gravis (MG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Myasthenia Gravis (MG)

Study ID

NCT07787247

Start date

Aug 19, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

18 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Subject Study Completion [ Time Frame: 12 months ]
  • Datasets retrieved from study assessments [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

The George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Principal Investigator:

Henry J Kaminski, M.D.

More Information

Sponsor

George Washington University

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • telemedicine
  • myasthenia gravis
  • remote monitoring
  • feasibility study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-08-26.