[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610380":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":21,"responsibleParty":40,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"BioSensics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"gMG group",null,"All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Ashkan Vaziri, PhD","CONTACT","8885896213","ashkan.vaziri@biosensics.com",{"name":19,"role":15,"phone":16,"phoneExt":10,"email":20},"Ana Enriquez","ana.enriquez@biosensics.com",[22],{"facility":23,"status":10,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Massachusetts General Hospital, Neuromuscular Diagnostic Center","Boston","Massachusetts","02114","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-71.05977,42.35843,{"lat":33,"lon":32},[36],{"name":37,"role":15,"phone":38,"phoneExt":10,"email":39},"Amanda Guidon, MD MPH","617-726-3642","aguidon@mgb.org",{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[43],{"name":44,"class":45},"Massachusetts General Hospital","OTHER","100610380","quantification-of-change-in-mg-disease-activity-in-individuals-with-generalized-myasthenia-gravis-gmg-after-administration-of-vyvgart-or-vyvgart-hytrulo-using-biodigit-mg-100610380",false,"NCT07226830","Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG","BioDigit MG-03","Inclusion Criteria:\n\n* Diagnosis of autoimmune MG with or without history of thymoma\n* MGFA severity class IIa\u002Fb, IIIa\u002Fb or IVa\u002Fb at the screening visit\n* Diagnosed gMG through one or more of the following:\n* Positive acetylcholine receptor antibody (AChR Ab) test, or\n* Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or\n* Documented positive response to standard MG therapies (e.g., AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors)\n* Currently initiating treatment with VYVGART® or VYVGART Hytrulo®\n* Physically and cognitively able to provide informed consent and adhere to the study procedures, as determined by the investigator.\n* Ambulatory, defined as the ability to walk at least 10 meters independently, with or without the use of an assistive device.\n* Speaks and reads English fluently\n\nExclusion Criteria:\n\n* Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance.\n* Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning.\n* Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity.\n* Current residence in a long-term care or institutional facility (e.g., nursing home, skilled nursing facility), receipt of hospice care, or incarceration.\n* MGFA severity classification of Class I or Class V (myasthenic crisis). Pregnant or breastfeeding women.\n* Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted).","ALL","18 Years","80 Years",{"count":57,"type":58},25,"ESTIMATED","OBSERVATIONAL","Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®.\n\nStudy subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 16 week observational study.\n\nStudy subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits.\n\nThe primary objective of this observational clinical study is to remotely evaluate MG-specific outcomes using digital health technologies in individuals with gMG during two treatment cycles with VYVGART® or VYVGART Hytrulo®.",[62],"Myasthenia Gravis Generalized",[64,65,66],"myasthenia gravis","digital health","wearable sensors","NOT_YET_RECRUITING","2025-11-09",{"date":70,"type":71},"2025-11-12","ACTUAL",{"date":73,"type":58},"2026-01-15",{"date":75,"type":58},"2028-03-31",{"name":5,"class":6},1]