Multi-Modal Monitoring of Disease Symptoms in Myasthenia Gravis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBioSensics
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Autoimmune MG with or without history of thymoma, MGFA severity Class IIa/b, IIIa/b or IVa/b at the screening visit
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
Disqualifiers
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.
Trial population
Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Myasthenia Gravis
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline 12 months.2
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.
Time frame
From baseline to 12 months.Secondary outcomes
1
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.
Time frame
From baseline to 12 months.2
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.
Time frame
From baseline to 12 months.3
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.
Time frame
From baseline to 12 months.4
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.
Time frame
From baseline to 12 months.Other outcomes
1
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.
Time frame
From baseline to 12 months.2
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
Time frame
From baseline to12 months3
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.
Time frame
From baseline to 12 months4
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.
Time frame
From baseline to 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
BioSensics
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: