OVEMP in Myasthenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Myasthenia Gravis, Ocular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Patients with clinical suspicion of ocular myasthenia gravis

Group Type EXPERIMENTAL

Ocular vestibular evoced myogenic potentials

Intervention Type DIAGNOSTIC_TEST

The oVEMP technique is an accepted standard for testing otolith function in vestibular patients. It represents a quick, simple and non-invasive technique utilizing repetitive stimulation of the otolith organs with bone-conducted vibration to elicit an extraocular muscle response. Repetitive oVEMP stimulation leads to a characteristic decrement in patients with myasthenia, which can be quantified with surface electromyography from the inferior oblique muscle underneath the eye.

Interventions

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Ocular vestibular evoced myogenic potentials

The oVEMP technique is an accepted standard for testing otolith function in vestibular patients. It represents a quick, simple and non-invasive technique utilizing repetitive stimulation of the otolith organs with bone-conducted vibration to elicit an extraocular muscle response. Repetitive oVEMP stimulation leads to a characteristic decrement in patients with myasthenia, which can be quantified with surface electromyography from the inferior oblique muscle underneath the eye.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No