NCT07224386Not yet recruiting
Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Evaluate the feasibility of using digital health technologies to monitor symptoms in myasthenia gravis (MG). Study subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 12 month observational study. Study subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits. The primary objective for this observational study is to measure the correlation of sensor-derived measures of physical activity to MG-specific ratings of MG-ADL, QMG, MGC, and Neuro-QoL Fatigue
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 29 Oct 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- BioSensics
- Diseases
- Myasthenia gravis
- NCT number
- NCT07224386
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)
Lab values
- 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.
Other
- Inability to engage in activities that are essential for independent living, such as dressing, bathing, toileting, or eating independently.
- Neurological or orthopedic problems independent of myasthenia which significantly affect gait and ADLs in the investigator's judgement.
- Residence in long-term care centers or institutions, nursing facilities, skilled nursing facilities, or recipients of hospice care, or incarceration.
- MGFA severity class I or V (MG crisis)
- Pregnant women.
Who the study is looking for
- Autoimmune MG with or without history of thymoma, MGFA severity Class IIa/b, IIIa/b or IVa/b at the screening visit
- Diagnosed gMG through ONE of the following methods:
- Positive acetylcholine receptor antibody (AChR Ab) test
- Positive muscle specific kinase receptor antibody (MuSK Ab) test
- Positive LRP4 antibody and abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG/PLEX, FcRn antagonists or C5 inhibitors
- Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS) OR has maintained a positive response to treatments such as AChE inhibitors, IVIG/PLEX, FcRn antagonists or C5 inhibitors.
- Physically and cognitively able to provide informed consent and adhere to the protocol, as determined by the investigator's judgment
- Ambulatory status defined as the ability to walk a distance of 10 meters independently, with or without the use of an assistive device
- Male or female, between the ages of 18 years old and 80 years old
- Speaks and reads English fluently
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital, Neuromuscular Diagnostic Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.