Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06277830

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Wearable sensor

Study Details

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

Study ID

NCT06277830

Start date

Feb 14, 2024

Status verified date

Feb, 2024

Completion date

Jun, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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)

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Primary outcome [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Carina C Stafstrom, BS

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Carina Stafstrom, BS

cstafstrom@mgh.harvard.edu

617-726-5175

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 4, 2024

Last verified

Feb, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2024-03-04.