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RecruitingNCT07787247ROME-MGUpdated Oct 5, 2026

Feasibility of Remote Monitoring of Patients With Myasthenia Gravis

An observational study in Myasthenia Gravis (MG), sponsored by George Washington University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by George Washington University · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 144 studies in Myasthenia Gravis with a site in United States — 53 open to participants now, 73 under way, 25 of them phase 3. Myasthenia Gravis · United States.

Planned enrollment
33rd of 36
18 · median 226
Started
2026
with 16 others
Observational
36 of 144
22 open now
Primary completion
2028-10
later than 48 of 72 live
Registered
144th of 144
by date

Among the 144 studies in Myasthenia Gravis with a site in United States, this one is the 33rd largest by planned enrollment of the 36 observational ones that give a count, is one of 17 that started in 2026, is one of 36 observational ones, reaches primary completion later than 48 of the 72 other live ones, and was the 144th registered.

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

Browse Myasthenia Gravis studies →

Open to participants now

53 of the 144 studies in Myasthenia Gravis with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 53 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 144 studies in Myasthenia Gravis with a site in United States, or all of them as a file.
02

Study 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

03

Conditions studied

  • Myasthenia Gravis (MG)

Browse trials for

Keywords

  • telemedicine
  • myasthenia gravis
  • remote monitoring
  • feasibility study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Myasthenia Gravis Patients who satisfy the study's eligibility criteria

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject

  1. Has the capacity to understand and sign an form
  2. ≥18 years old
  3. Diagnosed with acquired 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

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 -
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Subject Study Completion

    Proportion of subjects complete the 12-month study

    Time frame: 12 months

  2. Datasets retrieved from study assessments

    Proportion of assessments provide data sets that can be analyzed

    Time frame: 12 months

Secondary outcomes

  1. Subject Satisfaction

    Proportion of subjects indicate satisfaction with outcome measure assessment

    Time frame: 12 months

  2. Myasthenia Gravis-Activities of Daily Living and Myasthenia Gravis-Core Examination

    Correlation of Myasthenia Gravis-Core Examination individual assessments to Myasthenia Gravis-Activities of Daily Living assessments

    Time frame: 12 months

  3. Fitbit correlation

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

    Time frame: 12 months

  4. Hospital Anxiety and Depression Scale

    Utilizing Hospital Anxiety and Depression Scale questionnaire

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • The George Washington University
    Washington D.C., District of Columbia 20037, United States
    Recruiting
    • Gulsen Oztosun, M.D. · Contactromemgstudy@gwu.edu · 202-677-6109
    • Henry J Kaminski, M.D. · Principal investigator
08

References and documents

Publications

  • Garbey M, Lesport Q, Girma H, Oztosun G, Abu-Rub M, Guidon AC, Juel V, Nowak RJ, Soliven B, Aban I, Kaminski HJ. Application of digital tools and artificial intelligence in the Myasthenia Gravis Core Examination. Front Neurol. 2024 Dec 4;15:1474884. doi: 10.3389/fneur.2024.1474884. eCollection 2024. PubMed 39697445 ↗
09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Oct 2028, 26 months after the start.

Of 62 observational studies under Myasthenia Gravis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24. This study's planned 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2026
First posted
Aug 26, 2026
StartActual
Aug 19, 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2028
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 edited, 1 description edited
What changed in the outcomes
  • ChangedBefore MG-ADL and MG-CENow Myasthenia Gravis-Activities of Daily Living and Myasthenia Gravis-Core ExaminationTime frame: 12 months
  • DescriptionHospital Anxiety and Depression Scale: how it is measured was reworded
Sep 29, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • The George Washington University · Washington D.C., United StatesContact g•••@gwu.edu→r•••@gwu.edu
Oct 5, 2026
Show all 2 updates
  1. Oct 5, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • The George Washington University · Washington D.C., United StatesContact g•••@gwu.edu→r•••@gwu.edu
    + 1 other change: verification date
  2. Sep 29, 2026
    Secondary outcomes 1 edited, 1 description edited
    What changed in the outcomes
    • ChangedBefore MG-ADL and MG-CENow Myasthenia Gravis-Activities of Daily Living and Myasthenia Gravis-Core ExaminationTime frame: 12 months
    • DescriptionHospital Anxiety and Depression Scale: how it is measured was reworded
    + 3 other changes: verification date, date precision and responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07787247
Lead sponsor
George Washington University
Collaborators
EMD Serono Research & Development Institute, Inc.
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Aug 19, 2026
Primary completion
Oct 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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