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Physical Activity Monitoring in Myasthenia Gravis

RECRUITINGSponsored by Massachusetts General Hospital
Actively Recruiting
SponsorMassachusetts General Hospital
Started2024-02-14
Est. completion2024-06
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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)

Conditions2

CancerMyasthenia Gravis

Locations1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114
Carina Stafstrom, BScstafstrom@mgh.harvard.edu

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