MRI of eye muscles in myasthenia gravis
- Conditions
- Myasthenia gravis, Graves' orbitopathy
- Registration Number
- NL-OMON23441
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Recently diagnosed MG patients
- Definitive diagnosis of MG defined as the presence of serum autoantibodies (anti—acetylcholine receptor [AChR],
anti-muscle specific tyrosine kinase [MUSK])
- Start of symptoms was less than a year ago
- No corticosteroid treatment received in the past year
- No TSH-receptor auto-antibodies, no laboratory signs of thyroid dysfunction (T4, TSH), Chronic MG patients
- Definitive diagnosis of MG, defined as described above
- Persisting symptoms of diplopia
- Start of symptoms was more than a year ago
- No TSH-receptor auto-antibodies, no laboratory signs of thyroid dysfunction (T4, TSH), Seronegative MG
patients
- Clinical diagnosis of MG with asymmetric, fluctuating and fatigable muscle weakness and at least one abnormal
neurophysiological test, indicative of neuromuscular dysfunction (repetitive nerve stimulation or single fiber EMG)
- No serum autoantibodies (anti—acetylcholine receptor [AChR], anti-muscle specific tyrosine kinase [MuSK])
- No TSH-receptor auto-antibodies, no laboratory signs of thyroid dysfunction (T4, TSH)
Healthy controls
- No symptoms of diplopia
- No ophthalmopathy
- No prior systemic treatment with corticosteroids, Patient controls: Graves' orbitopathy
- Definitive diagnosis of Graves' orbitopathy, Patient controls: Other neuromuscular disease
- Definitive diagnosis of a neuromuscular disease other than Myasthenia gravis
- Subjects who are not legally capable
- Subjects under the age of 18
- Contraindications to MRI scanning, including:
o Claustrophobia
o Pregnancy
o Pacemakers and defibrillators
o Nerve stimulators
o Intracranial clips
o Metallic fragments
o Cochlear implants
o Ferromagnetic implants
o Hydrocephalus pump
o Permanent make-up
o Tattoos above the shoulders
o Piercings (unless they can be removed)
o Subjects who cannot keep their head still (eg. Tremor, Parkinson's disease)
o Severe physical restriction (completely wheelchair dependent)
? In the case of uncertainty about the MRI-contraindications, the MR-safety commission of the radiology
department will decide whether this subject can be included in the study or not.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) QMRI parameters (muscle fat fraction, muscle inflammation, muscle volume) which are hypothesized to differ between MG<br>patients and the healthy/disease controls for diagnostic value.<br>(2) For the second objective comparing recently diagnosed and chronic MG patients for exploring the pathophysiology
- Secondary Outcome Measures
Name Time Method (3) For the third objective comparing the gMRI parameters in time in the recently diagnosed MG group to measures of severity of<br>disease to assess the predictive value for treatment response.<br>(4) For the fourth objective comparing gMRI parameters to functional measures in all groups for exploring the relationship with the<br>symptoms