Myasthenia GravisNCT05564936
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
A study testing ME&MG mobile application in people with Myasthenia Gravis, run by Ad scientiam at 19 sites in 2 countries.
Trial summary
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- ME&MG mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 24 Jan 2024to 24 Sep 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged over 18 Years
- Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
- With positive serologic testing for anti-AChR autoantibody at screening
- Have read the information sheet and signed the informed consent form
- Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
- Able to use a smartphone
- Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms
Who cannot join
- Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
- Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Pregnant and nursing women
- Person under guardianship or curatorship
- Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
- Participant included in another ME\&MG clinical study
- Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
United States11 sites, 10 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80204
Thomas Ragole, Dr, 303-724-2188, thomas.ragole@cuanschutz.edu
Dr Ragole
- Completed
HealthParterns Institute
Bloomington, Indiana, 47401
- Recruiting
Duke University
Durham, North Carolina, 27708
Shruti Raja, Dr, 919-684-5422, shruti.raja@duke.edu
Dr Raja
- Recruiting
Indiana University Health
Indianapolis, Indiana, 46123
Sara M Takacs, 3179485450, stakacs@iuhealth.org
- Recruiting
University of Florida Health
Jacksonville, Florida, 32209
Michael T Pulley, (904) 383-1022, michael.pulley@jax.ufl.edu
- Not yet recruiting
The University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Christopher Dr Scheiner, 856-521-6174, cscheiner@utmck.edu
Dr Scheiner
- Recruiting
Neurological Associates of Long Island, P.C.
Lake Success, New York, 11042
Denis Ostrovskiy, MD, (516) 466-4700, dostrovskiy@neuroli.com
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Ima M Ebong, 8592571000, Ima.Ebong@uky.edu
- Recruiting
Vanderbilt Health
Nashville, Tennessee, 37232
Lindsay Malatesta, Dr, 615 936-0600, lindsay.malatesta@vumc.org
Dr Malatesta
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19144
Erika Wong, Dr, 215 955-4672, Ericka.Wong@jefferson.edu
Dr Wong
- Recruiting
OHSU
Portland, Oregon, 97239
Nizar Chahin, Dr, 503-494-7772, chahin@ohsu.edu
Dr Chahin
France8 sites, 7 recruiting
- Recruiting
Hôpital Raymond Poincaré
Garches, 92380
Pr Pascal Laforet, 01.47.10.77.36, pascal.laforet@aphp.fr
Dr Edouard Berling
- Not yet recruiting
CHU Grenoble
Grenoble
Dr Lagrange, +33 476767575, elagrange@chu-grenoble.fr
Dr Lagrange
- Recruiting
Hôpital Salengro
Lille
Dr Tard, +33 3 20 44 59 62, CELINE.TARD@chru-lille.fr
Dr Tard
- Recruiting
CHRU Nancy
Nancy, 54035
Dr Michaud, +33 3 83 85 85 85, m.michaud@chru-nancy.fr
Dr Michaud
- Recruiting
CHU Nantes
Nantes
Dr Péréon, +33 0240083617, Yann.Pereon@univ-nantes.fr
Dr Péréon
- Recruiting
Pitié-Salpêtrière
Paris, 75013
Anthony Behin, Dr, +33 142163774, anthony.behin@aphp.fr
Anthony Behin, Dr
- Completed
CHU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67200
- Recruiting
CHU Toulouse
Toulouse
Dr Cintas, +33 5 61 77 94 40, cintas.p@chu-toulouse.fr
Dr Cintas
About this study
Official title: The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Read the detailed description
Myasthenia gravis (MG) is an autoimmune neuromuscular disease characterised by fatigable muscle weakness due to autoantibodies targeting components of the neuromuscular junction.
Deficits are measured using validated clinical scales such as the Quantitative Myasthenia Gravis score (QMG) QMG, Myasthenia Gravis Composite Score (MCS), Myasthenia Gravis Activities of Daily Living score (MG-ADL), etc., Unfortunately, this type of assessment might require expensive material, time, and personnel training, which make MG assessment difficult for clinicians in routine care.
Research on the matter has highlighted the importance of Patient-Reported Outcomes (PROs), composite measures of disease severity and quality-of-life measurements. This has led to the development of a number of tools for the self-assessment of PROs with validated questionnaires. However, there is no tool that overcomes the constraints of standard tests such as the QMG while allowing for the collection of objective data and PROs between visits.
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
- Conditions
- Myasthenia Gravis
- Being tested
- ME&MG mobile application
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME&MG mobile applicationDevice
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
| Study group | Role | What they receive |
|---|---|---|
| MG patients | Experimental | MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months Receives: Device: ME&MG mobile application |
| Healthy volunteers | Other | Healthy volunteers will perform one in-clinic visit and will use the app at-home once Receives: Device: ME&MG mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions
Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests
Measured: baseline
Secondary outcomes (13)
To compare results between in-clinic digital tests and in-clinic standard tests, test to test
pearson correlation coefficient between digital tests and standard tests
Measured: baseline
To assess reproducibility between in-clinic digital tests and at-home digital tests
intraclass correlation coefficient
Measured: baseline, day 1, day 89, day 90
To assess test-retest reliability of at-home digital tests
intraclass correlation coefficient mean k raters (ICCk; k=day)
Measured: Day1, Day 2, Day 3, Day 87, Day 88, Day 89
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score
Pearson correlation coefficient between digital composite score and QMG score
Measured: baseline, day 1
To assess adverse events related to the use of the mobile application
Descriptive analysis of adverse events (AEs) related to the use of the application
Measured: through study completion, an average of 1 year
To assess satisfaction and user experience with the smartphone application
descriptive analysis of questionnaires resulsts
Measured: through study completion, an average of 1 year
To assess correlation of the at-home ME&MG composite score with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Pearson's correlation coefficient between ME\&MG composite score and MG-ADL scores
Measured: baseline, day 90, day 365
to assess daily activites
Myasthenia Gravis Activities of Daily Living (MG-ADL)
Measured: 12 months
to assess depression
Patient Health Questionnaire-8 (PHQ8)
Measured: 12 months
to assess pain
pain likert scale
Measured: 12 months
to assess insomnia
Insomnia Severity Index
Measured: 12 months
To assess at-home compliance to the ME&MG smartphone application
descriptive analysis of adherence data
Measured: through study completion, an average of 1 year
To assess quality of life
36-Item Short Form Survey (SF-36)
Measured: Baseline, day 90, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start24 Jan 2024
- Primary completion24 Sep 2025 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564936
- Sponsor's protocol ID
- DOMYA
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study
- ClinicalTrials.gov ID
- NCT05564936
- Acronym / sponsor ID
- DOMYA
- Conditions
- Myasthenia Gravis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 24 Sep 2025 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 4 Oct 2022 (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.
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Detailed description
Myasthenia gravis (MG) is an autoimmune neuromuscular disease characterised by fatigable muscle weakness due to autoantibodies targeting components of the neuromuscular junction.
Deficits are measured using validated clinical scales such as the Quantitative Myasthenia Gravis score (QMG) QMG, Myasthenia Gravis Composite Score (MCS), Myasthenia Gravis Activities of Daily Living score (MG-ADL), etc., Unfortunately, this type of assessment might require expensive material, time, and personnel training, which make MG assessment difficult for clinicians in routine care.
Research on the matter has highlighted the importance of Patient-Reported Outcomes (PROs), composite measures of disease severity and quality-of-life measurements. This has led to the development of a number of tools for the self-assessment of PROs with validated questionnaires. However, there is no tool that overcomes the constraints of standard tests such as the QMG while allowing for the collection of objective data and PROs between visits.
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.
ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG patients | Experimental | Device: ME&MG mobile applicationMG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months |
| Healthy volunteers | Other | Device: ME&MG mobile applicationHealthy volunteers will perform one in-clinic visit and will use the app at-home once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged over 18 Years
- Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
- With positive serologic testing for anti-AChR autoantibody at screening
- Have read the information sheet and signed the informed consent form
- Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
Key exclusion criteria (8 listed)
- Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
- Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
- Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
- Pregnant and nursing women
- Person under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ME&MG mobile applicationME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. | Device | Healthy volunteers, MG patients |
Primary outcome
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions
Time frame: baseline
Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests
13 secondary outcomes
To compare results between in-clinic digital tests and in-clinic standard tests, test to test
Time frame: baseline
To assess reproducibility between in-clinic digital tests and at-home digital tests
Time frame: baseline, day 1, day 89, day 90
To assess test-retest reliability of at-home digital tests
Time frame: Day1, Day 2, Day 3, Day 87, Day 88, Day 89
To compare results obtained with the at-home ME&MG composite score and the in-clinic standard QMG composite score
Time frame: baseline, day 1
To assess adverse events related to the use of the mobile application
Time frame: through study completion, an average of 1 year
To assess satisfaction and user experience with the smartphone application
Time frame: through study completion, an average of 1 year
To assess correlation of the at-home ME&MG composite score with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Time frame: baseline, day 90, day 365
to assess daily activites
Time frame: 12 months
to assess depression
Time frame: 12 months
to assess pain
Time frame: 12 months
to assess insomnia
Time frame: 12 months
To assess at-home compliance to the ME&MG smartphone application
Time frame: through study completion, an average of 1 year
To assess quality of life
Time frame: Baseline, day 90, Day 365
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 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ME&MG mobile application in people with Myasthenia Gravis, run by Ad scientiam at 19 sites in 2 countries.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France. 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 Pr Laforet (+33147107752, pascal.laforet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025; AzTrials last refreshed its copy on 3 Nov 2026.