Physical Activity Monitoring in Myasthenia Gravis

NCT06277830 | Recruiting FDA Device

• 1 other identifier: 2023P002788
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myasthenia Gravis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exploratory outcome

  1 week

Study Arms (1)

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

Interventions

Wearable sensor DEVICE

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.

Also known as: Tablet-based physical examination

Adults with autoimmune myasthenia gravis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• BioSensics: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Amanda C Guidon, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina C Stafstrom, BS

CONTACT

617-726-5175; cstafstrom@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology/Harvard Medical School

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 26, 2024
• Study Start: February 14, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)