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Ocular vestibular evoked myogenic potentials in patients with myasthenia gravis

Ocular vestibular evoked myogenic potentials in patients with myasthenia gravis - oVEMPs in patients with myasthenia gravis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50285
Enrollment
136
Registered
2018-10-01
Start date
2018-10-19
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

myasthenia myasthenia gravis

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Cross-sectional study (objective 1) Patients with MG: * Patient is legally capable * Definitive diagnosis of MG defined as the presence of a typical history and at least one positive ancillary test, including edrophonium testing, RNS, and serum autoantibodies (anti-acetylcholine receptor [AChR], anti-muscle specific tyrosine kinase [MuSK]). Healthy controls: * Healthy control is legally capable * No diagnosis of MG * Absence of disease that involves eye-muscle function or any other muscle disease Controls with other neuromuscular diseases: * Patient is legally capable * No diagnosis of MG * Definite diagnosis of other neuromuscular disease Controls non-neuromuscular diseases that can cause diplopia: * Patient is legally capable * No diagnosis of MG * No other neuromuscular disease * Definite diagnosis that can cause diplopia * Presence of diplopia Longitudinal study (objective 2) Patients with the clinical suspicion of MG: * Patient is legally capable * MG is in the differential diagnosis * No definitive diagnosis of MG' Neostigmine study (objective 3) Patients who undergo an acetylcholinesterase inhibitor (neostigmine) test within routine clinical care: * Patient is legally capable * MG is in the differential diagnosis * Patient undergoes neostigmine test for diagnostic purposes

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:, * Patients who are legally incapable * Patients who are under the age of 16 * Patients with known vestibulo-cochlear disorders

Design outcomes

Primary

MeasureTime frame
1. The endpoint for objective 1 is the amount of decrement. We will investigate cross-sectionally which cut-off value results in the best combination of sensitivity and specificity by calculating a ROC curve. We will compare this cut-off value with that of Valko et al..

Secondary

MeasureTime frame
2. The endpoint for objective 2 is the presence of significant decrement, using the cut-off value established in objective 1 in order to calculate the specificity and sensitivity of the oVEMP test longitudinally. 3. The endpoint for objective 3 is the decrease of decrement. We will study whether decrement decreases after administration of acetylcholinesterase inhibitors (neostigmine test). 4. The endpoint in objective 4 is the reproducibility of decrement in two consecutive measurements in the same subjects.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)