Clinical trial · Observational
Physical Activity Monitoring in Myasthenia Gravis
Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis
- 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)
The goal of this observational study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG). The main question\[s\] it aims to answer are: * To measure the correlation of sensor-based measures of motor function with existing outcome measures including the MG-ADL, MGQOL15r, QMG, MGComposite, and Neuro-QOL Fatigue scales. * To develop and validate tablet-based digital assessments of speech and facial expression and to compare with existing outcome measures. Participants will wear a pendant sensor for 7 days and then participate in tablet-based and in-person myasthenia-specific physical examinations. This will be performed in concert with routine care in the Massachusetts General Hospital MG clinic.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable sensor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with autoimmune myasthenia gravis
- description
- Existing patients at MassGeneral Hospital's MG clinic, ages 18-80, with autoimmune, AChR or MuSK antibody positive generalized myasthenia gravis.
- interventionNames
- Device: Wearable sensor
Primary outcomes (1)
- measure
- Primary outcome
- timeFrame
- 1 week
- description
- To measure the correlation of sensor-based measures of motor function to the MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.
Secondary outcomes (1)
- measure
- Exploratory outcome
- timeFrame
- 1 week
- description
- To develop and validate digital assessment of speech and facial expression compared to rating of MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Autoimmune generalized MG with or without history of thymoma, MGFA severity Class Ila/b, Illa/b or IVa * Acetylcholine receptor antibody (AChR Ab) or muscle specific kinase receptor antibody (MuSK Ab) positive. * Able to provide informed consent (physically/cognitively) and adhere with the protocol based on investigator's judgement * Ambulatory, defined as able to independently walk a distance of 10 meters, with or without assistive device * Male or female, aged 18-80 years * Speaks English as primary language Exclusion Criteria: * Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, eating independently. * Neurological or orthopedic problems independent of myasthenia which significantly affects gait 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 IVb (severe bulbar weakness) or V (MG crisis) * Pregnant or breastfeeding women * Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)
References
Publications (0)
Data not yet available