NCT07146425

Construction of A Multimodal Digital Assessment Model for Myasthenia Gravis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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: 1. Perform a descriptive analysis and comparison of phenotypic data across various subgroups to pinpoint key characteristics associated with MG disease grade and scale score. 2. 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. 3. Develop a patient-centric remote evaluation system utilizing the refined MG digital evaluation model to facilitate its application in real-world clinical settings.

Conditions

• Myasthenia Gravis

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: China