RECRUITING

Physical Activity Monitoring in Myasthenia Gravis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-14
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06277830

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Autoimmune generalized MG with or without history of thymoma, MGFA severity Class Ila/b, Illa/b or IVa
  2. * Acetylcholine receptor antibody (AChR Ab) or muscle specific kinase receptor antibody (MuSK Ab) positive.
  3. * Able to provide informed consent (physically/cognitively) and adhere with the protocol based on investigator's judgement
  4. * Ambulatory, defined as able to independently walk a distance of 10 meters, with or without assistive device
  5. * Male or female, aged 18-80 years
  6. * Speaks English as primary language
  1. * Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, eating independently.
  2. * Neurological or orthopedic problems independent of myasthenia which significantly affects gait in the investigator's judgement
  3. * 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
  4. * Residence in long-term care centers or institutions, nursing facilities, skilled nursing facilities, or recipients of hospice care, or incarceration
  5. * MGFA severity class IVb (severe bulbar weakness) or V (MG crisis)
  6. * Pregnant or breastfeeding women
  7. * Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)

Contacts and Locations

Study Contact

Carina C Stafstrom, BS
CONTACT
617-726-5175
cstafstrom@mgh.harvard.edu

Principal Investigator

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

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-14
Study Completion Date2024-06

Study Record Updates

Study Start Date2024-02-14
Study Completion Date2024-06

Terms related to this study

Keywords Provided by Researchers

  • telemedicine
  • wearable sensors
  • outcome measures
  • digital health
  • biomarkers
  • clinical trials

Additional Relevant MeSH Terms

  • Myasthenia Gravis