Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
Condition(s) studied
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Massachusetts General Hospital, Neuromuscular Diagnostic Center | Boston | Massachusetts |
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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