Clinical trial · Interventional
OVEMP in Myasthenia
Diagnostic Accuracy of Repetitive Ocular Vestibular Evoked Myogenic Potentials in Myasthenia Gravis (OMG Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Myasthenia gravis is an autoimmune disorder of neuromuscular transmission, characterized by fluctuating muscle weakness and fatigability. In isolated ocular myasthenia, when only the extraocular muscles are involved, most common ancillary tests, such as acetylcholine receptor autoantibodies and repetitive nerve stimulation, are often negative. A simple, quick and non-invasive test for ocular myasthenia based on ocular vestibular evoked myogenic potentials (oVEMP) was recently developed. The main goal of the study is to validate repetitive oVEMP stimulation in a blinded diagnostic accuracy study in order to facilitate early and accurate diagnosis of ocular myasthenia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis, Ocular | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ocular vestibular evoced myogenic potentials | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with clinical suspicion of ocular myasthenia gravis
- interventionNames
- Diagnostic Test: Ocular vestibular evoced myogenic potentials
Primary outcomes (1)
- measure
- Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
- timeFrame
- The primary outcome measure (index test oVEMP) will be assessed at baseline, in conjunction with reference standard/standard clinical workup (including blood analysis, neurological exam, edrophonium test, electromyography, single-fiber electromyography).
- description
- oVEMP have been established as a standard clinical test of otolith function. Based on this technique, repetitive oVEMP stimulation, as a novel method for detecting ocular myasthenia gravis, was recently developed. Using this method, a response decrement in extraocular muscles can be quantified. The method is based on the conventional oVEMP montage with surface electrodes placed below the eyes. In order to elicit a response decrement, trains of ten bone-conducted vibration bursts at repetition rates of 20Hz will be applied with a hand-held 'minishaker' to the forehead. The oVEMP in response to these repetitive vibration stimuli will be measured in sustained upgaze from both inferior oblique muscles via surface electrodes. The magnitude of the decrement will be calculated as the difference between the amplitude of the second stimulus repetition and the mean amplitude of the fifth to ninth stimulus repetition. For further Information see: Valko et al. 2016 PMID:26791146
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent as documented by signature * Patients with diplopia and/or ptosis suspicious for myasthenia gravis. Exclusion Criteria: * Vestibular disorders * Significant systemic myasthenia symptoms (respiration or swallowing difficulties) unable to undergo oVEMP testing. * Patients with significant cardiac or respiratory disease will be excluded from the Tensilon test as part of the reference standard. * Women who are pregnant or breast feeding.
References
Publications (3)
- BACKGROUNDValko Y, Rosengren SM, Jung HH, Straumann D, Landau K, Weber KP. Ocular vestibular evoked myogenic potentials as a test for myasthenia gravis. Neurology. 2016 Feb 16;86(7):660-8. doi: 10.1212/WNL.0000000000002383. Epub 2016 Jan 20. PMID 26791146
- DERIVEDHandzic A, Furter MP, Messmer BC, Wirth MA, Valko Y, Fierz FC, Margolin EA, Weber KP. Multivariable Prediction Model for Suspected Ocular Myasthenia Gravis: Development and Validation. J Neuroophthalmol. 2026 Mar 1;46(1):47-53. doi: 10.1097/WNO.0000000000002346. Epub 2025 Apr 21. PMID 40257852
- DERIVEDValko Y, Wirth MA, Fierz FC, Schesny MK, Rosengren S, Schmuckle-Meier T, Bockisch CJ, Straumann D, Schreiner B, Weber KP. Accuracy of Repetitive Ocular Vestibular-Evoked Myogenic Potentials to Diagnose Myasthenia Gravis in Patients With Ptosis or Diplopia. Neurology. 2024 May;102(10):e209395. doi: 10.1212/WNL.0000000000209395. Epub 2024 Apr 26. PMID 38669629