Myasthenia gravis: diagnostic, prognostic, and treatment response markers
- Conditions
- G70Myasthenia gravis and other myoneural disorders
- Registration Number
- DRKS00024428
- Lead Sponsor
- Klinik für NeurologieNeuroCure Clinical Research Center (NCRC)Charité Universitätsmedizin BerlinCharité Campus Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1600
Inclusion criteria Myasthenia patients:
- Confirmed diagnosis of myasthenia gravis.
- Men and women
- Ability to give consent
- Written informed consent
Inclusion criteria Controls:
- Men and women
- Capacity to consent
- Written informed consent
Group 1: age-matched, no neurological diseases with motor impairments, no autoimmunological diseases, no depression.
Group 2: age-matched, other neuroimmunological diseases (e.g. multiple sclerosis, immune neuropathies)
General Exclusion Criteria:
- Lack of communication skills
- Alcohol or drug abuse (current)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of risk factors as well as predictive biomarkers (immune markers, gene markers) in the early course of the disease (<12 months after first symptom) for progression (pure ocular, generalized or myasthenic crisis within 36 months).<br>The planned study is a mixed prospective and retrospective observational study.<br>Many parameters (antibody status, imaging of the thymus) are part of routine clinical diagnostics for MG patients. <br>A special clinical examination (Q-motor), which allows quantification of motor functions by means of instrumental diagnostics, is used. The aim of this Q-motor examination is to compare its results with the results of the current diagnostic standard, the Besinger Score. In addition, it is a goal to use a very sensitive method to determine to what extent patients who are clinically assessed as having ocular progression do not have signs of generalization that are difficult to recognize.
- Secondary Outcome Measures
Name Time Method Identification of markers for response to specific therapies and for long-term disease progression, as well as for specific MG-specific findings through the systematic collection and analysis of the parameters described above.