Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis

NCT07224386 | Not Yet Recruiting

• 2 other identifiers: BioDigit MG-02R44NS122672
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myasthenia Gravis; Myasthenia Gravis, Generalized

Keywords

myasthenia gravis; digital health; wearable sensors

Outcome Measures

Primary Outcomes (2)

• Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant

  Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, 3 month, 6 month, 9 month, and 12 month visits.

  From baseline 12 months.

• Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 12 months as measured by the PAMSys pendant.

  Daily number of sit to stand transitions will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, 3 month, 6 month, 9 month, and 12 month visits.

  From baseline to 12 months.

Secondary Outcomes (7)

• Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech

  From baseline to 12 months.

• Change in Marginal Reflex Distance-1 during the upward gaze test as measured by BioDigit Video from baseline to 12 months

  From baseline to 12 months.

• Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 12 months

  From baseline to 12 months.

• Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 12 months

  From baseline to 12 months.

• Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 12 months

  From baseline to 12 months.

Other Outcomes (5)

• Change in daily mean heart rate (beats per minute or BPM) during activities of daily living from baseline to 12 months as measured by the Samsung Galaxy watch

  From baseline to 12 months.

• Change in forced vital capacity during a standard spirometer breathing test from baseline to 12 months as measured by a FDA-listed spirometer

  From baseline to12 months

• Change in articulatory rate when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech

  From baseline to 12 months

Study Arms (1)

Myasthenia Gravis

All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

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

Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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 I or V (MG crisis)
• Pregnant women.
• Concurrent participation in an interventional clinical trial (observational studies, biomarker studies and registries are acceptable)

Sponsors & Collaborators

• BioSensics: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital, Neuromuscular Diagnostic Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Mishra RK, Potter IY, Enriquez A, Stafstrom CL, Sheitman Z, Lindsay A, Barchard G, Nunes AS, Duda PW, Vaziri A, Guidon AC. Development and Feasibility Assessment of a Multimodal Digital Health Technology for Remote Monitoring of Symptoms in Myasthenia Gravis. Digit Biomark. 2025 Oct 23;9(1):193-202. doi: 10.1159/000549122. eCollection 2025 Jan-Dec.

  PMID: 41322084 BACKGROUND

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

Central Study Contacts

Ashkan Vaziri, PhD

CONTACT

8885896213; ashkan.vaziri@biosensics.com

Ana Enriquez

CONTACT

88858962113; ana.enriquez@biosensics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 4, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: November 4, 2025

Record last verified: 2025-10

Locations

US (1)