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NCT Number: NCT07787247

Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The George Washington University

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

Location status: Recruiting

Location contact

Gulsen Oztosun, M.D.

CONTACT

[email protected]

202-677-6109

Henry J Kaminski, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject

  • Has the capacity to understand and sign an informed consent form
  • ≥18 years old
  • 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
  • Subject has been previously evaluated in a face-to-face clinical encounter at participating study site or referral site within the prior 3 years
  • Primary language is English, or equivalent level of English language fluency
  • 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.
  • Having MG-ADL score above 2 upon entrance to study
  • Patients considered by study PI not to require hospitalization at time of entrance
  • The patient has internet capability and a smart phone compatible with the apps required by the study.

Exclusion criteria

Disease Specific Exclusion Criteria

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

Treatment and study plan

Primary outcomes

  1. Subject Study Completion

    Time frame: 12 months

    Proportion of subjects complete the 12-month study

  2. Datasets retrieved from study assessments

    Time frame: 12 months

    Proportion of assessments provide data sets that can be analyzed

Secondary outcomes

  1. Subject Satisfaction

    Time frame: 12 months

    Proportion of subjects indicate satisfaction with outcome measure assessment

  2. MG-ADL and MG-CE

    Time frame: 12 months

    Correlation of MG-CE individual assessments to MG-ADL assessments

  3. Fitbit correlation

    Time frame: 12 months

    Correlation of Fitbit metrics to MG-ADL and MG-CE

  4. Hospital Anxiety and Depression Scale

    Time frame: 12 months

    Utilizing HADS questionnaire

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

Pilot Study: Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

Acronym: ROME-MG

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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