Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBioSensics
About this trial
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 criteria
Qualifiers
Autoimmune MG with or without history of thymoma, MGFA severity Class IIa/b, IIIa/b or IVa/b at the screening visit
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
50 Participants
are grouped into 1 trial groupSponsors and collaborators
BioSensics
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov