Clinical trial · Observational
Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
NCT07224386CI-TRIAL-00096949BioDigit MG-02not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
| Myasthenia Gravis, Generalized | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Myasthenia Gravis
- description
- All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities
Primary outcomes (2)
- measure
- Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant
- timeFrame
- From baseline 12 months.
- description
- 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.
- measure
- 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.
- timeFrame
- From baseline to 12 months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDMishra RK, Potter IY, Enriquez A, Stafstrom CL, Sheitman Z, Lindsay A, Barchard G, Nunes AS, Duda PW, Vaziri A, Guidon AC. Development and Feasibility Assessment of a Multimodal Digital Health Technology for Remote Monitoring of Symptoms in Myasthenia Gravis. Digit Biomark. 2025 Oct 23;9(1):193-202. doi: 10.1159/000549122. eCollection 2025 Jan-Dec. PMID 41322084