Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis

Fudan University

Status

Enrolling

Conditions

Myasthenia Gravis

Study type

Observational

Funder types

Other

Identifiers

NCT07146425

KY2023-664

Details and patient eligibility

About

This research is a single-center, exploratory, observational study to be carried out in the outpatient or inpatient ward of the Neurology Department at Huashan Hospital, affiliated to Fudan University. The aim is to develop a digital assessment model for Myasthenia Gravis by gathering multimodal digital phenotypic data from MG patients. This includes physiological signals, facial videos, eye movements, speech, limb movements, various scales, and quality of life metrics.

Full description

The goal is to define the multimodal digital phenotypes of myasthenia gravis patients, determine the specificities of their symptoms, and develop a digital evaluation model and remote assessment system that is objective, precise, and user-friendly. This will provide a scientific foundation and technical support for diagnosing, treating, and rehabilitating individuals with MG.

Key issues to be addressed include:

Whether digital phenotyping can comprehensively represent the disease characteristics and severity gradations in MG.
The feasibility of using multimodal digital phenotypic modeling for the objective evaluation of MG.
The challenges and obstacles faced by the AI-enhanced medical model in clinical demonstration applications.

The study is focused on three main objectives:

Perform a descriptive analysis and comparison of phenotypic data across various subgroups to pinpoint key characteristics associated with MG disease grade and scale score.
Construct a digital evaluation model for MG patients using chosen features, validate the model with prospectively gathered data, and conduct a correlative analysis with the clinical functional scales to assess its effectiveness on predicting MG symptom grading and disease progression.
Develop a patient-centric remote evaluation system utilizing the refined MG digital evaluation model to facilitate its application in real-world clinical settings.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For Patients with MG

Patients have a confirmed diagnosis of myasthenia gravis and be over 18 years old.
Patients have the clinical classification of Myasthenia Gravis Foundation of America (MGFA) within I-IV, or be asymptomatic after treatment.
Patients must sign the informed consent form and the privacy confidentiality agreement.

For Healthy Participants

Age group matched with MG participants

Exclusion criteria

For Patients with MG

Patients are in the crisis stage of myasthenia gravis (MGFA class V) and unable to cooperate with scoring.
Patients are with severe cardiopulmonary diseases and unable to cooperate with the scoring.
Patients with any psychiatric disorder or cognitive dysfunction that, in the investigator's judgment, may interfere with their participation in the study.
Patients with any other unspecified unstable medical condition.