Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis (BioDigit MG-02)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Myasthenia Gravis; Myasthenia Gravis, Generalized

Detailed Description

MG is a chronic autoimmune neuromuscular disease characterized by fluctuating muscle weakness that interferes with activities of daily living. Ocular, facial, swallowing, neck, limb and breathing muscles can be affected. The prevalence of MG is estimated at approximately 60,000 patients in the United States. MG symptoms are currently assessed in person through a careful history and physical exam by a neuromuscular disease expert. This is time-consuming, costly, and poses challenges in a chronic disease with fluctuating symptoms, where patients may not demonstrate any abnormality at the time of in-clinic assessment. The principal means of measuring disease severity are specific scales such as the MGC, QMG and the MG Manual Muscle Testing (MMT) scales. Although valuable, these scales are subjective and require training to administer correctly. Additionally, they provide only snapshot of a patient's disease and do not adequately reflect the spectrum of fluctuating weakness, which is a hallmark of MG. Wearable sensors and digital health technologies could enable objective, sensitive, continuous assessment of physical activity as well as motor and ocular impairments in individuals with MG.

BioSensics LLC (Newton, MA) is a medical device company specializing in wearable sensors and digital health technology for healthcare. BioSensics LLC offers a wearable sensor system and digital health solution for long-term remote monitoring of motor performance during everyday life.

The first phase of this project (NCT06277830) was conducted by Dr. Amanda Guidon at MGB, recruiting 20 patients with generalized MG over the course of 5 months to test initial feasibility of BioDigit MG.

This is an analytic observational study following participants over the course of 12 months. Subjects with documented diagnosis of MG with MGFA severity classes IIa/b, IIIa/b or IVa/b will be screened and recruited to participate in this non--interventional study.

The objective of the study is to evaluate the feasibility of using wearable sensors and digital health technologies to measure motor and speech function, as well as developing measures of ocular and facial expression to monitor the progression of the disease for people with MG. To achieve these objectives, we will conduct an observational study to investigate the correlation between outcomes as measured by the PAMSys sensor and digital health technologies with the total score and sub-scores of MG-ADL, QMG, MGC, and Fatigue Short Form of the Neuro-QOL in individuals with different MGFA severity Classes (Class IIa/b, IIIa/b or IVa/b).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ashkan Vaziri, PhD; Phone Number: 8885896213; Email: ashkan.vaziri@biosensics.com
• Study Contact Backup: Name: Ana Enriquez; Phone Number: 88858962113; Email: ana.enriquez@biosensics.com

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital, Neuromuscular Diagnostic Center
      • Contact: Amanda Guidon; Phone Number: 617-726-3642; Email: aguidon@mgb.org
      • Principal Investigator: Amanda Guidon, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Myasthenia Gravis; All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech	Speech data will be collected from participants while reading a standard Rainbow passage on a biweekly basis for 12 months. BioDigit Speech, and automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.	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	Video data will be collected from participants while performing a standard upward gaze test on a biweekly basis for 12 months. BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate Marginal Reflex Distance-1 during the upward gaze test.	From baseline to 12 months.
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 12 months	Scores for the MG-ADL range from 0-24. A lower score represents a better outcome and a higher score is a worse outcome. Collected every two weeks.	From baseline to 12 months.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 12 months	Scores for the MGC range from 0-50. A lower score represents a better outcome and a higher score is a worse outcome. Collected every 3 months.	From baseline to 12 months.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 12 months	Scores for the MGQoL-15R range from 0-30. A lower score represents a better outcome and a higher score is a worse outcome. Collected every two weeks.	From baseline to 12 months.
Change in total score of the Quantitative Myasthenia Gravis (QMG) scale from baseline to 12 months	Scores for the QMG range from 0-39. A lower score represents a better outcome and a higher score is a worse outcome. Collected every 3 months.	From baseline to 12 months.
Change in total score of Quality of Life in Neurological Disorders - Fatigue (Neuro-QoL Fatigue) from baseline to 12 months.	Scores for the Neuro-QoL Fatigue range from 8-40. A lower score represents a better outcome and a higher score is a worse outcome. Collected every two weeks.	From baseline to 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Heart rate will be measured during activities of daily living using the Samsung Galaxy watch. Samsung Galaxy watch will be worn continuously from 1 week prior to baseline until the 12 month visit.	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	Forced vital capacity (FVC) will be measured directly by the spirometer during a standard breathing assessment. The FVC will be measured in Litres. FVC will be collected biweekly from baseline to 12 months	From baseline to12 months
Change in articulatory rate when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech	Speech data will be collected from participants while reading a standard Rainbow passage on a biweekly basis for 12 months. BioDigit Speech, and automatic speech analysis software, will be used to analyze the collected speech data to calculate articulatory rate during reading a standard Rainbow passage.	From baseline to 12 months
Change in eye aspect ratio during the upward gaze test as measured by BioDigit Video from baseline to 12 months	Video data will be collected from participants while performing a standard upward gaze test on a biweekly basis for 12 months. BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate eye aspect ratio during the upward gaze test.	From baseline to 12 months.
Change in daily mean heart rate variability during activities of daily living from baseline to 12 months as measured by the Samsung Galaxy watch	Heart rate variability will be measured during activities of daily living using the Samsung Galaxy watch. Samsung Galaxy watch will be worn continuously from 1 week prior to baseline until the 12 month visit.	From baseline to 12 months.

Collaborators and Investigators

• Sponsor: BioSensics
• Collaborators: Massachusetts General Hospital; National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

General Publications

• Ram Kinker Mishra, İlkay Yıldız Potter, Ana Enriquez, Carina L. Stafstrom, Zoe Sheitman, Abigail Lindsay, Gregory Barchard, Adonay S. Nunes, Petra W. Duda, Ashkan Vaziri, Amanda C. Guidon; Development and Feasibility Assessment of a Multi-Modal Digital Health Technology for Remote Monitoring of Symptoms in Myasthenia Gravis. Digit Biomark 2025; https://doi.org/10.1159/000549122

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: digital health; myasthenia gravis; wearable sensors
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Myasthenia Gravis
• Other Study ID Numbers: BioDigit MG-02; R44NS122672 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No