Monitoring physical activity in patients with Myasthenia Gravis
Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis
This study tests if wearable sensors can help track movement and speech in adults with Myasthenia Gravis to better understand their changing symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06277830 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the feasibility of using wearable sensors and digital technologies to measure motor and speech function in adults with autoimmune Myasthenia Gravis (MG). Participants will wear a pendant sensor for 7 days and undergo both tablet-based and in-person assessments at the Massachusetts General Hospital MG clinic. The study seeks to correlate sensor-based measures with existing outcome measures and develop digital assessments for speech and facial expression. This approach aims to provide a more comprehensive understanding of fluctuating symptoms in MG patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with autoimmune generalized Myasthenia Gravis who can provide informed consent and are ambulatory.
Not a fit: Patients with significant neurological or orthopedic issues affecting gait or those unable to perform essential daily activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of Myasthenia Gravis symptoms, enhancing patient quality of life.
How similar studies have performed: While the use of wearable technology in chronic disease monitoring is gaining traction, this specific approach in Myasthenia Gravis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Amanda C Guidon, MD, MPH — Mass. General Hospital
- Study coordinator: Carina C Stafstrom, BS
- Email: cstafstrom@mgh.harvard.edu
- Phone: 617-726-5175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.