An interventional study of MyoSense 360 in Myasthenia Gravis, Generalized, sponsored by Ad scientiam. Recruiting at 20 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Ad scientiam · Not applicable, Interventional, and Other
The purpose of the HARMONY 360 investigation is to explore the feasibility of using MyoSense 360 digital measures to develop models capable of detecting clinically meaningful changes in generalized Myasthenia Gravis (gMG) trajectory over 12 months under real-world conditions. Its main objective is not yet to demonstrate the final conformity of the device (exploratory study under article 82), but to collect preliminary data of safety and clinical performance that will help to refine the final product and inform the subsequent pivotal study.
The primary objective focuses on developing models to detect disease trajectory changes defined by the clinically significant +/- 2 points MG-ADL threshold. Secondary objectives include assessing usability, adherence, and the feasibility of models for worsening/exacerbation prediction. Finally, risks and anticipated Adverse Device Effects (ADEs) associated with the device use will be monitored continuously throughout the investigation. Consistent with its Proof of Concept stage, the study defines no claims of clinical performance, effectiveness or safety.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
This study's planned enrollment of 100 is above the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Ad scientiam is the lead sponsor of 14 studies on the registry; 5 are open to participants now.
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Positive antibody testing for ACHR or MuSK antibodies; or,
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Performance of digital tests (only at D0), digital questionnaires and standard test in clinic at D0, D180 and D360 Use of MyoSense 360 at-home in between visits during 12 months of follow-up and answer ePRO
Device: MyoSense 360
The investigational version of MyoSense 360 consists of two mobile applications running on the patient's smartphone (CentrePoint Connect and InClinical), an ActiGraph LEAP activity monitor (Ametris product), as well as two cloud computing platforms
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to detect changes in disease trajectory in adults with generalized Myasthenia Gravis over a 12-month period, under real-life, unsupervised conditions.
The primary endpoint will be the ability of the model to detect changes categorized as a 3-class variable: * improved: decreased Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥2 points * unchanged: increased or decreased MG-ADL total score \<2 points * worsening: increased MG-ADL total score by ≥2 points
Time frame: 12 months
To explore the feasibility of using digital measures collected by MyoSense 360 to develop models to predict sustained worsening within a one-month forward-looking window
The first secondary endpoint will be the ability of the model to detect changes categorized as a 2-class variable: * worsening: increased MG-ADL total score by ≥2 points * other: either decreased MG-ADL total score ≥2 points or increased or decreased in MG-ADL total score \<2 points
Time frame: 1 month
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics: \- Positive predictive value
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics: \- time-to-event accuracy
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests combined measures in a model, obtained at home, without supervision and the standard reference QMG sub-items scores performed under clinical supervision at baseline.
Feasibility of using MyoSense 360 developed models to predict sustained worsening, i.e., an increase by at least 2-points in MG-ADL total score that is sustained within the next 4 weeks (no change observed in the opposite direction) will be described through performance metrics: \- Model robustness across patients.
Time frame: 4 weeks
To describe the association between MyoSense 360 active functional tests measures obtained at home without supervision and the standard reference Quantitative Myasthenia Gravis (QMG) sub-items performed under clinical supervision at baseline
A correlation coefficient will be used to assess the relationship between the MyoSense 360 active functional tests at Day 1 (D1, at home) and standard tests at Day 0 (D0, in clinic). The endpoint will be considered positive if one test meets the expected correlation, with a minimum correlation threshold of r = 0.50 for the following comparisons: * "My Eyelids" Test (MET) and ptosis in QMG * "My Voice" Test (MVT) and onset of dysarthria in QMG * "My Breathing" Test (MBT) and vital capacity in QMG * "My Arms" test (MAT) and upper limb weakness in QMG * "My Legs" Test (MLT) and lower limb weakness in QMG
Time frame: Day 0 and Day 1
To describe the association between digital measures from MyoSense 360 (ActiGraph LEAP data collection, active smartphone functional tests and electronic Patient-Reported Outcomes) and clinical and patient-reported outcome measures
Cross-sectional and longitudinal associations between MyoSense 360 digital measures and clinical and patient-reported outcomes measured through questionnaires will be described using mixed-models
Time frame: 12 months
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Compliance to MyoSense 360 will be described through: \- The number of days with valid\* data collection from the wearable device. \*The minimum requirement is 8 hours of daytime wear per day, with at least 60% daily compliance throughout the one-year follow-up period. Additionally, patients should wear the ActiGraph LEAP during at least two nights per week to capture relevant sleep and resting heart rate measures.
Time frame: 12 months
To describe the usability of MyoSense 360, including ActiGraph LEAP data collection, active functional tests and ePROs, from the patient's perspective.
Usability of MyoSense 360 will be described using the System Usability Scale (SUS): \- A descriptive analysis of the responses collected in the SUS related to the use of MyoSense 360 at Days 1, 180 and 345
Time frame: Days 1, 180 and 345
To describe participant compliance to the use of the MyoSense 360, including ActiGraph LEAP data collection all along the study, number of active functional tests performed and ePROs completed
Compliance to MyoSense 360 will be described through: \- The proportion of scheduled active functional tests completed per patient over time in comparison to the total expected
Time frame: 12 months
To describe overall patient satisfaction and perceived benefits of using MyoSense 360 in daily life
Descriptive analysis of the answers collected in the patient's satisfaction and perceived benefits questionnaires related to the use of MyoSense 360
Time frame: Days 1, 180 and 345
To monitor the incidence, type, and severity of adverse events and device deficiencies related to the use of MyoSense 360.
All adverse events (AEs), serious adverse events (SAEs) and Device Deficiencies (DD), and new findings on previous SAEs and DDs, suspected to be related to MyoSense 360 or not, will be prospectively collected from the first device use until 30 days after the last study activity, in line with ISO 14155:2020 and EU MDR 2017/745.
Time frame: 390 days
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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