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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Carina C Stafstrom, BS
cstafstrom@mgh.harvard.edu
617-726-5175
Time Frame
Start Date: 2024-02-14
Estimated Completion Date: 2024-06
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: BioSensics

This content was sourced from clinicaltrials.gov