Characteristics and Prognostic Outcomes of Diaphragmatic Ultrasound in Myasthenia Gravis

November 25, 2024 updated by: Fei Xiao, First Affiliated Hospital of Chongqing Medical University

The goal of this observational study is to learn about the characteristics and prognostic outcomes of diaphragmatic ultrasound in myasthenia gravis. The main question it aims to answer is:

Does diaphragmatic ultrasound predict prognosis of myasthenia gravis in six months? Participants diagnosed as myasthenia gravis will take the diaphragm ultrasound examinations.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors; Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins; Repeated electrical stimulation examination showed a decrease in wave amplitude.

Description

Inclusion Criteria:

  • 1: Patients who seek treatment at the First Affiliated Hospital of Chongqing Medical University and have fluctuating skeletal muscle weakness and at least one of the following three conditions will be included: positive reaction to cholinesterase inhibitors

    2: Serum positive antibodies against acetylcholine receptors, muscle specific kinases, or lipoprotein related proteins

    3: Repeated electrical stimulation examination showed a decrease in wave amplitude.

Exclusion Criteria:

  • 1: Patients with lung disease or heart failure, or a history of non-invasive ventilator or tracheotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
controls
myasthenia gravis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QMG changes
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in medication type or dose
Time Frame: 6 months
acetylcholinesterase inhibitors, glucocorticoid, immunosuppressant
6 months
respiratory infection
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-050-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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