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Quantitative MRI of extra-ocular muscles in myasthenia gravis

Quantitative MRI of extra-ocular muscles in myasthenia gravis - Quantitative MRI of extra-ocular muscles in myasthenia gravis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48436
Enrollment
130
Registered
2019-06-25
Start date
2019-09-27
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
(3) For the third objective comparing the qMRI parameters in time in the recently diagnosed MG group to measures of severity of disease to assess the predictive value for treatment response. (4) For the fourth objective comparing qMRI parameters to functional measures in all groups for exploring the relationship with the symptoms

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)