[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653594":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":33,"armGroups":29,"interventions":29,"overallOfficials":29,"centralContacts":29,"locations":34,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":29,"enrollmentInfo":74,"targetDuration":29,"studyType":77,"phases":29,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":37,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"George Washington University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Subject Study Completion","Proportion of subjects complete the 12-month study","12 months",{"measure":14,"description":15,"timeFrame":12},"Datasets retrieved from study assessments","Proportion of assessments provide data sets that can be analyzed",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"Subject Satisfaction","Proportion of subjects indicate satisfaction with outcome measure assessment",{"measure":21,"description":22,"timeFrame":12},"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",{"measure":24,"description":25,"timeFrame":12},"Fitbit correlation","Correlation of Fitbit metrics to MG-ADL and MG-CE",{"measure":27,"description":28,"timeFrame":12},"Hospital Anxiety and Depression Scale","Utilizing Hospital Anxiety and Depression Scale questionnaire",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Myasthenia Gravis Patients who satisfy the study's eligibility criteria",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The George Washington University","RECRUITING","Washington D.C.","District of Columbia","20037","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.03637,38.89511,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":29,"email":54},"Gulsen Oztosun, M.D.","CONTACT","202-677-6109","romemgstudy@gwu.edu",{"name":56,"role":57,"phone":29,"phoneExt":29,"email":29},"Henry J Kaminski, M.D.","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[61],{"name":62,"class":63},"EMD Serono Research & Development Institute, Inc.","INDUSTRY","100653594","feasibility-of-remote-monitoring-of-patients-with-myasthenia-gravis-100653594",false,"NCT07787247","Feasibility of Remote Monitoring of Patients With Myasthenia Gravis","Pilot Study: Feasibility of Remote Monitoring of Patients With Myasthenia Gravis","ROME-MG","Inclusion Criteria:\n\nSubject\n\n1. Has the capacity to understand and sign an informed consent form\n2. ≥18 years old\n3. Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and\u002For a decremental response on repetitive nerve stimulation, positive single fiber electromyography (EMG) or positive edrophonium test\n4. Subject has been previously evaluated in a face-to-face clinical encounter at participating study site or referral site within the prior 3 years\n5. Primary language is English, or equivalent level of English language fluency\n6. 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.\n7. Having MG-ADL score above 2 upon entrance to study\n8. Patients considered by study PI not to require hospitalization at time of entrance\n9. The patient has internet capability and a smart phone compatible with the apps required by the study.\n\nExclusion Criteria:\n\nDisease Specific Exclusion Criteria\n\n1. Inability to comply with study protocol for monitoring\n2. Current MGFA Severity Class IVb or V, or patients in remission with MGFA Class 0\n3. Any significant medical\u002Fpsychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance\n4. Any disorder that could limit ability to assess myasthenia gravis specific deficits (not including planned or recent thymectomy)\n5. Pregnancy, based on the evaluator's judgment, if the subject is deemed not safe to undergo evaluation or comply with study visit requirements.\n6. Lack of effective internet connection or ability to use study telemedicine station and monitors\n7. Home environment prevents use of study equipment\n8. Likelihood of leaving DC, Maryland, or Virginia area in year after initiation of study\n9. Subject is already participating in a research study -","ALL","18 Years",{"count":75,"type":76},18,"ESTIMATED","OBSERVATIONAL","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",[80],"Myasthenia Gravis (MG)",[82,83,84,85],"telemedicine","myasthenia gravis","remote monitoring","feasibility study","2026-10-02",{"date":88,"type":89},"2026-10-05","ACTUAL",{"date":91,"type":89},"2026-08-19",{"date":93,"type":76},"2028-10",{"name":5,"class":6},1]