Myasthenia GravisBioDigit MG-02NCT07224386
Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
An observational study of Myasthenia Gravis and Myasthenia Gravis, Generalized, run by BioSensics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis, Myasthenia Gravis, Generalized
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital, Neuromuscular Diagnostic Center
Boston, Massachusetts, 02114
Amanda Guidon, 617-726-3642, aguidon@mgb.org
Amanda Guidon, MD MPH
About this study
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
Read the 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).
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Generalized
- Keywords
- myasthenia gravis, digital health, wearable sensors
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myasthenia Gravis | All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224386
- Sponsor's protocol ID
- BioDigit MG-02
- Other IDs
- R44NS122672
- Acronym
- BioDigit MG-02
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41322084
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07224386
- Acronym / sponsor ID
- BioDigit MG-02 / BioDigit MG-02
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Generalized
- Keywords
- myasthenia gravis, digital health, wearable sensors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Massachusetts General Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myasthenia Gravis | – | –All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant
Time frame: From baseline 12 months.
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.
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.
Time frame: From baseline to 12 months.
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.
7 secondary outcomes
Change in intelligibility when reading a standard Rainbow passage from baseline to 12 months as measured by BioDigit Speech
Time frame: 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
Time frame: From baseline to 12 months.
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 12 months
Time frame: From baseline to 12 months.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 12 months
Time frame: From baseline to 12 months.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 12 months
Time frame: From baseline to 12 months.
Change in total score of the Quantitative Myasthenia Gravis (QMG) scale from baseline to 12 months
Time frame: 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.
Time frame: From baseline to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Background: PubMed 41322084Mishra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis and Myasthenia Gravis, Generalized, run by BioSensics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashkan Vaziri, PhD (8885896213, ashkan.vaziri@biosensics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily walking duration during activities of daily living from baseline to 12 months as measured by the PAMSys pendant (time frame: From baseline 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07224386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.