Uses wearable sensors to track muscle weakness in myasthenia gravis patients
Monitors myasthenia gravis symptoms at home during treatment with Vyvgart or Vyvgart Hytrulo.
Plain-language title generated from the registry record
Registry title: Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
Key facts
- Where
- Boston, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07226830, who can take part
Where in United States
- Massachusetts General Hospital, Neuromuscular Diagnostic CenterBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioSensics
- Trial code
- NCT07226830
- Record updated
- 13 October 2026
- Original description
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®.Read full original descriptionShow less
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
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®.
Study subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 16 week 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.
The 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®.
Inclusion: Diagnosis of autoimmune MG with or without history of thymoma; MGFA severity class IIa/b, IIIa/b or IVa/b at the screening visit; Diagnosed gMG through one or more of the following:; Positive acetylcholine receptor antibody (AChR Ab) test, or; Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or; Documented positive response to standard MG therapies (e.g., AChE inhibitors, IVIG/PLEX, FcRn antagonists or C5 inhibitors); Currently initiating treatment with VYVGART® or VYVGART Hytrulo®; Physically and cognitively able to provide informed consent and adhere to the study procedures, as determined by the investigator; Ambulatory, defined as the ability to walk at least 10 meters independently, with or without the use of an assistive device; Speaks and reads English fluently.
Exclusion: Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted); Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning; Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity; Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance; Current residence in a long-term care or institutional facility (e.g., nursing home, skilled nursing facility), receipt of hospice care, or incarceration; MGFA severity classification of Class I or Class V (myasthenic crisis). Pregnant or breastfeeding women.