Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
BioSensics
Study ID
NCT07224386
Status
Not Yet Recruiting

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Conditions

  • Myasthenia Gravis
  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jan 1, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Myasthenia Gravis
    All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

Primary Outcome Measure

Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant [ Time Frame: From baseline 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital, Neuromuscular Diagnostic CenterBostonMassachusetts02114
Amanda Guidon
617-726-3642
Amanda Guidon, MD MPH (PRINCIPAL_INVESTIGATOR)

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