Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
Starting soon
Conditions studied: Myasthenia Gravis, Myasthenia Gravis, Generalized
In brief
Evaluate the feasibility of using digital health technologies to monitor symptoms in myasthenia gravis (MG). Study 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. The 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
Key facts
- Study ID
- NCT07224386
- Run by
- BioSensics
- People needed
- 50
- Starts
- 2026-01-01
- Expected to finish
- 2028-04-30
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 of the following methods:
- Positive acetylcholine receptor antibody (AChR Ab) test
- Positive muscle specific kinase receptor antibody (MuSK Ab) test
- 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/PLEX, FcRn antagonists or C5 inhibitors
- 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/PLEX, FcRn antagonists or C5 inhibitors.
- Physically and cognitively able to provide informed consent and adhere to the protocol, as determined by the investigator's judgment
- Ambulatory status defined as the ability to walk a distance of 10 meters independently, with or without the use of an assistive device
- Male or female, between the ages of 18 years old and 80 years old
- Speaks and reads English fluently
You may not qualify if…
- Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, or eating independently.
- Neurological or orthopedic problems independent of myasthenia which significantly affect gait and ADLs in the investigator's judgement.
- 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.
- Residence in long-term care centers or institutions, nursing facilities, skilled nursing facilities, or recipients of hospice care, or incarceration.
- MGFA severity class I or V (MG crisis)
- Pregnant women.
- Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)
Where it is running
- Massachusetts General Hospital, Neuromuscular Diagnostic Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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