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Starting soon Observational

Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis

NCT07224386 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Observational
Started
2026-01-01
Last updated
2025-11-04

Condition(s) studied

Myasthenia GravisMyasthenia Gravis, Generalized

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

  • Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant — From baseline 12 months.
    Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, 3 month, 6 month, 9 month, and 12 month visits.
  • Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 12 months as measured by the PAMSys pendant. — From baseline to 12 months.
    Daily number of sit to stand transitions will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, 3 month, 6 month, 9 month, and 12 month visits.

Trial sites (1)

FacilityCityRegionStatus
Massachusetts General Hospital, Neuromuscular Diagnostic Center Boston Massachusetts
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224386 on ClinicalTrials.gov ↗ ← All trials in the USA