Trial Title:
The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
NCT ID:
NCT05564936
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
ME&MG mobile application
Description:
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.
Arm group label:
Healthy volunteers
Arm group label:
MG patients
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 Years to 60 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
Exclusion Criteria:
- Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous
Immunoglobulin Therapy within four weeks of 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of Florida Health
Address:
City:
Jacksonville
Zip:
32209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michael T Pulley
Phone:
904-383-1022
Email:
michael.pulley@jax.ufl.edu
Facility:
Name:
Indiana University Health
Address:
City:
Indianapolis
Zip:
46123
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sara M Takacs
Phone:
317-948-5450
Email:
stakacs@iuhealth.org
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ima M Ebong
Phone:
859-257-1000
Email:
Ima.Ebong@uky.edu
Facility:
Name:
Neurological Associates of Long Island, P.C.
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Recruiting
Contact:
Last name:
Denis Ostrovskiy, MD
Phone:
516-466-4700
Email:
dostrovskiy@neuroli.com
Facility:
Name:
Hôpital Raymond Poincaré
Address:
City:
Garches
Zip:
92380
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Pascal Laforet
Investigator:
Last name:
Edouard Berling
Email:
Principal Investigator
Facility:
Name:
CHRU Nancy
Address:
City:
Nancy
Zip:
54035
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maud Michaud, Dr
Facility:
Name:
CHU de Strasbourg - Hôpital de Hautepierre
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aleksandra Nadaj Pakleza, Dr
Start date:
January 24, 2024
Completion date:
September 15, 2025
Lead sponsor:
Agency:
Ad scientiam
Agency class:
Other
Source:
Ad scientiam
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05564936
