Quantitative MRI of extra-ocular muscles in myasthenia gravis

Completed

• Conditions: Myasthenia gravis; 10030061; 10029317; 10028302

• Registration Number: NL-OMON48436
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-10-04
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 89

Inclusion Criteria

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

Exclusion Criteria

- 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
<p>(1) QMRI parameters (muscle fat fraction, muscle inflammation, muscle volume)<br /><br>which are hypothesized to differ between MG patients and the healthy/disease<br /><br>controls for diagnostic value.<br /><br>(2) For the second objective comparing recently diagnosed and chronic MG<br /><br>patients for exploring the pathophysiology</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(3) For the third objective comparing the qMRI parameters in time in the<br /><br>recently diagnosed MG group to measures of severity of disease to assess the<br /><br>predictive value for treatment response.<br /><br>(4) For the fourth objective comparing qMRI parameters to functional measures<br /><br>in all groups for exploring the relationship with the symptoms</p><br>