[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610192":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":22,"responsibleParty":44,"collaborators":46,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"BioSensics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Myasthenia Gravis",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":20,"phoneExt":10,"email":21},"Ana Enriquez","88858962113","ana.enriquez@biosensics.com",[23],{"facility":24,"status":10,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Massachusetts General Hospital, Neuromuscular Diagnostic Center","Boston","Massachusetts","02114","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-71.05977,42.35843,{"lat":34,"lon":33},[37,41],{"name":38,"role":15,"phone":39,"phoneExt":10,"email":40},"Amanda Guidon","617-726-3642","aguidon@mgb.org",{"name":42,"role":43,"phone":10,"phoneExt":10,"email":10},"Amanda Guidon, MD MPH","PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[47,50],{"name":48,"class":49},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":51,"class":52},"Massachusetts General Hospital","OTHER","100610192","multi-modal-monitoring-of-disease-symptoms-in-myasthenia-gravis-100610192",false,"NCT07224386","Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis","BioDigit MG-02","Inclusion Criteria:\n\n* Autoimmune MG with or without history of thymoma, MGFA severity Class IIa\u002Fb, IIIa\u002Fb or IVa\u002Fb at the screening visit\n* Diagnosed gMG through ONE of the following methods:\n\n  * Positive acetylcholine receptor antibody (AChR Ab) test\n  * Positive muscle specific kinase receptor antibody (MuSK Ab) test\n  * Positive LRP4 antibody and abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors\n  * Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG\u002FPLEX, FcRn antagonists or C5 inhibitors.\n* Physically and cognitively able to provide informed consent and adhere to the protocol, as determined by the investigator's judgment\n* Ambulatory status defined as the ability to walk a distance of 10 meters independently, with or without the use of an assistive device\n* Male or female, between the ages of 18 years old and 80 years old\n* Speaks and reads English fluently\n\nExclusion Criteria:\n\n* Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, or eating independently.\n* Neurological or orthopedic problems independent of myasthenia which significantly affect gait and ADLs in the investigator's judgement.\n* Any significant medical, laboratory, or psychiatric condition that, in the judgment of the investigators, would potentially interfere with the ability to participate in the study.\n* Residence in long-term care centers or institutions, nursing facilities, skilled nursing facilities, or recipients of hospice care, or incarceration.\n* MGFA severity class I or V (MG crisis)\n* Pregnant women.\n* Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)","ALL","18 Years","80 Years",{"count":64,"type":65},50,"ESTIMATED","OBSERVATIONAL","Evaluate the feasibility of using digital health technologies to monitor symptoms in myasthenia gravis (MG).\n\nStudy subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 12 month observational study. Study 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 for this observational study is to measure the correlation of sensor-derived measures of physical activity to MG-specific ratings of MG-ADL, QMG, MGC, and Neuro-QoL Fatigue",[9,69],"Myasthenia Gravis, Generalized",[71,72,73],"myasthenia gravis","digital health","wearable sensors","NOT_YET_RECRUITING","2025-10-31",{"date":77,"type":78},"2025-11-04","ACTUAL",{"date":80,"type":65},"2026-01-01",{"date":82,"type":65},"2028-04-30",{"name":5,"class":6},1]