Diagnostic Accuracy of Repetitive Ocular Vestibular Evoked Myogenic Potentials in Myasthenia Gravis (OMG Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
盲法说明
Blinded diagnostic accuracy study (index test vs. reference standard).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Patients with diplopia and/or ptosis suspicious for myasthenia gravis.
排除标准
- •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.
结局指标
主要结局
Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
时间窗: 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).
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
次要结局
未报告次要终点
研究者
Konrad Peter Weber
PD Dr.med.
University of Zurich