OVEMP in Myasthenia

Not Applicable

Completed

• Conditions: Myasthenia Gravis, Ocular
• Interventions: Diagnostic Test: Ocular vestibular evoced myogenic potentials

• Registration Number: NCT03049956
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-10
• Primary Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with clinical suspicion of ocular myasthenia gravis	Ocular vestibular evoced myogenic potentials	-

Primary Outcome Measures

Name	Time	Method
Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)	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

Trial Locations

Locations (1)

University Hospital Zurich, Ophthalmology/Neurology Department; 🇨🇭 Zurich, Switzerland