Physical Activity Monitoring in Myasthenia Gravis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Device: Wearable sensor

Detailed Description

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by fluctuating muscle weakness and symptoms that interfere with activities of daily living and negatively impacts quality of life. MG symptoms are currently assessed in person through a careful history and physical exam by a neuromuscular disease expert. Such in-clinic assessments are time-consuming, subjective, only provide a snapshot of a patient's disease and do not adequately reflect the spectrum of fluctuating weakness and symptoms. In 2019, NIH funded a rare disease clinical research consortium called MGNet. The consortium is focused on improved characterization of clinical phenotypes, discovery of biomarkers, and advancing clinical trial readiness for MG, which would enhance the development of more effective and personalized treatments. In this Fast Track SBIR project, BioSensics will collaborate with Massachusetts General Hospital - one of the key Consortium sites for MGNet - to develop and validate a wearable sensor solution (MGWear) for continuous remote monitoring of motor symptoms and function in MG patients and also a secure mobile application (MG app) for automatic assessment of speech and facial characteristics. The mobile application will also enable the transfer of data from the wearable device to BioSensics HIPAA-compliant backend cloud called BioDigit Cloud.

The objective of the study is to evaluate the feasibility of using wearable sensor and digital technologies to measure motor and speech function as well as developing metrics to measure ocular and facial expression to monitor disease activity and fluctuating muscle weakness in people with Myasthenia Gravis (MG).To achieve this objective, the investigators will conduct an observational study is to investigate the correlation between outcomes as measured by the PAMSys sensor and digital health technologies with the total score and sub-scores of MG specific outcome measures.

A key application and market for the proposed solution technology is pharmaceutical clinical trials. Wearable sensors and digital technologies like the technology proposed here could allow drug developers to test and iterate faster, providing a valuable new method for evaluating efficacy. Clinically, the proposed solution could be used to predict an individual's response to immunosuppressive drugs and to improve medication titration. Such solutions can enable detecting subtle changes in movement-based and digital biomarkers and provide insight into the phase of clinical disease onset. Additionally, the growing use of telemedicine to expand access and potentially reduce costs of high-quality care will require remote assessment strategies. 20% of states in the US (10 out of 50 states) have no specialized care for MG. Travel time, distance and cost may limit patients' access to expert care, even in states with identified MG specialists. The proposed remote monitoring technologies have potential to lessen barriers to quality care access for MG patients.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Carina C Stafstrom, BS; Phone Number: 617-726-5175; Email: cstafstrom@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Carina Stafstrom, BS; Email: cstafstrom@mgh.harvard.edu
      • Contact: Phone Number: 617-726-5175

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with generalized autoimmune myasthenia gravis who are existing patients in the Mass General Hospital Neuromuscular Clinic

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with autoimmune myasthenia gravis; Existing patients at MassGeneral Hospital's MG clinic, ages 18-80, with autoimmune, AChR or MuSK antibody positive generalized myasthenia gravis.	Device: Wearable sensor; Participants will wear a pendant sensor for 7 days and then participate in an on-site examination with using a tablet designed to evaluate weakness in MG.; Other Names: Tablet-based physical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	To measure the correlation of sensor-based measures of motor function to the MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory outcome	To develop and validate digital assessment of speech and facial expression compared to rating of MG-ADL, QMG, MGC, and Neuro-QOL Fatigue.	1 week

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: BioSensics
• Investigators: Principal Investigator: Amanda C Guidon, MD, MPH, Mass. General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 18, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; clinical trials; telemedicine; digital health; outcome measures; wearable sensors
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: 2023P002788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No