Physical Activity Monitoring in Myasthenia Gravis

Description

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

Myasthenia Gravis

Study Overview

Study Details

Study overview

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.

Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis

Physical Activity Monitoring in Myasthenia Gravis

Condition
Myasthenia Gravis
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Amanda C Guidon, MD, MPH, PRINCIPAL_INVESTIGATOR, Mass. General Hospital

Study Record Dates

2024-06