Myasthenia Gravis, OcularNCT03049956
OVEMP in Myasthenia
A study testing Ocular vestibular evoced myogenic potentials in people with Myasthenia Gravis, Ocular, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis, Ocular
- What is being tested?
- Ocular vestibular evoced myogenic potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent as documented by signature
- Patients with diplopia and/or ptosis suspicious for myasthenia gravis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Ophthalmology/Neurology Department
Zurich, 8091
About this study
Official title: Diagnostic Accuracy of Repetitive Ocular Vestibular Evoked Myogenic Potentials in Myasthenia Gravis (OMG Study)
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
- Myasthenia Gravis, Ocular
- Being tested
- Ocular vestibular evoced myogenic potentials
- Keywords
- Ocular Vestibular Evoked Myogenic Potentials
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular vestibular evoced myogenic potentialsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with clinical suspicion of ocular myasthenia gravis | Experimental | Not described Receives: Diagnostic Test: Ocular vestibular evoced myogenic potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
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
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Nov 2016
- Primary completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myasthenia Gravis, OcularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Peter Weber, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049956
- Sponsor's protocol ID
- 2016-01109
- Other IDs
- 2016
- Status last verified
- Jan 2021
- First submitted
- 1 Feb 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valko 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.
PubMed 26791146Handzic 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.
PubMed 40257852Valko 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.
PubMed 38669629
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Repetitive Ocular Vestibular Evoked Myogenic Potentials in Myasthenia Gravis (OMG Study)
- ClinicalTrials.gov ID
- NCT03049956
- Acronym / sponsor ID
- 2016-01109
- Conditions
- Myasthenia Gravis, Ocular
- Keywords
- Ocular Vestibular Evoked Myogenic Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with clinical suspicion of ocular myasthenia gravis | Experimental | Diagnostic Test: Ocular vestibular evoced myogenic potentials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed Consent as documented by signature
- Patients with diplopia and/or ptosis suspicious for myasthenia gravis.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular vestibular evoced myogenic potentialsThe 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. | Diagnostic test | Patients with clinical suspicion of ocular myasthenia gravis |
Primary outcome
Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Background: PubMed 26791146Valko 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.
- Derived from this study: PubMed 40257852Handzic 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.
- Derived from this study: PubMed 38669629Valko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular vestibular evoced myogenic potentials in people with Myasthenia Gravis, Ocular, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrement (as quantified in %) of repetitive 20 Hz ocular vestibular-evoked myogenic potentials (oVEMP) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03049956, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.