The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Ad scientiam
Study ID
NCT05564936
Status
Recruiting
Apply to this trial

Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ME&MG mobile application — DEVICE
    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 Details

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.

Key Dates

Start date
Jan 24, 2024
Status verified
Apr 2025
Primary completion
Sep 24, 2025
Completion
Sep 24, 2026

Study Design

Enrollment
144 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: MG patients
    MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months
  • Other: Healthy volunteers
    Healthy volunteers will perform one in-clinic visit and will use the app at-home once

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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80204
Thomas Ragole, Dr
[email protected]
303-724-2188
Dr Ragole (PRINCIPAL_INVESTIGATOR)
University of Florida HealthJacksonvilleFlorida32209
Michael T Pulley
[email protected]
(904) 383-1022
HealthParterns InstituteBloomingtonIndiana47401-
Indiana University HealthIndianapolisIndiana46123
Sara M Takacs
[email protected]
3179485450
University of KentuckyLexingtonKentucky40536
Ima M Ebong
[email protected]
8592571000
Neurological Associates of Long Island, P.C.Lake SuccessNew York11042
Denis Ostrovskiy, MD
[email protected]
(516) 466-4700
Duke UniversityDurhamNorth Carolina27708
Shruti Raja, Dr
[email protected]
919-684-5422
Dr Raja (PRINCIPAL_INVESTIGATOR)
OHSUPortlandOregon97239
Nizar Chahin, Dr
[email protected]
503-494-7772
Dr Chahin (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson UniversityPhiladelphiaPennsylvania19144
Erika Wong, Dr
[email protected]
215 955-4672
Dr Wong (PRINCIPAL_INVESTIGATOR)
The University of Tennessee Medical CenterKnoxvilleTennessee37920
Christopher Dr Scheiner
[email protected]
856-521-6174
Dr Scheiner (PRINCIPAL_INVESTIGATOR)
Vanderbilt HealthNashvilleTennessee37232
Lindsay Malatesta, Dr
[email protected]
615 936-0600
Dr Malatesta (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Denver· Aurora, COUniversity of Florida Health· Jacksonville, FLHealthParterns Institute· Bloomington, INIndiana University Health· Indianapolis, INUniversity of Kentucky· Lexington, KYNeurological Associates of Long Island, P.C.· Lake Success, NY

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