Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexander Tarnutzer
About this trial
BACKGROUND: A chief complaint of acute vertigo/dizziness is related to about 2.1-7.1% of all emergency department (ED) visits. About 25% of all patients with acute prolonged vertigo meeting diagnostic criteria of AVS (acute vestibular syndrome) suffer from a vertebrobasilar stroke and about 35% of these patients are initially missed. Differentiating dangerous central from more benign peripheral causes of AVS is essential. Subtle oculomotor paradigms such as HINTS (Head-Impulse, Nystagmus, Test-of-Skew) have been shown to detect central causes with high diagnostic accuracy, however, require sufficient training. Thus, identifying other bedside tests that can be reliably performed by frontline providers is essential to reduce misdiagnosis.
WORKING HYPOTHESIS: By using additional oculomotor (saccades, pursuit) and pupillomotor parameters at the bedside or quantitatively, the diagnostic accuracy for distinguishing peripheral from central AVS causes can be further improved, especially in the setting when expertise for applying more sophisticated algorithms (HINTS(+), STANDING) is lacking.
AIM 1: Detecting changes in oculomotor and pupillomotor responses in acutely dizzy patients and characterizing the spectrum of abnormalities in peripheral and central AVS.
AIM 2: Comparing different composite oculomotor-/pupillomotor scores to identify those scores with the highest diagnostic accuracy at the bedside and quantitatively.
AIM 3: Comparing the diagnostic accuracy of bedside and quantitative oculomotor and pupillomotor testing in AVS- identifying potential limitations of bedside testing.
METHODS: To assess oculomotor and pupillomotor responses in patients with peripheral or central AVS and healthy controls (25 participants each) at the bedside and quantitatively by use of a Pioneer research eye tracker (PRET) system and to compare the diagnostic accuracy of individual and composite responses.
EXPECTED VALUE OF THE PROJECT: The proposed project will shed more light on the value of different examination techniques in AVS for distinguishing peripheral from central causes. This is achieved by investigating oculomotor and pupillomotor parameters obtained at the bedside and quantitatively in the acute stage and at follow-up. The insights gained will likely have a direct impact on diagnostic accuracy and thus on future strategies how to evaluate acutely dizzy patients in the ED. Eventually, this may reduce the rate of misdiagnosis and may improve patients' outcome.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient groups
patients presenting with an AVS (peripheral or central), with symptom duration of 5 days or less
being able to receive brain MRI
Being able to give informed consent as documented by signature
Disqualifiers
Aged less than 18 years.
Pregnant or lactating women
Inability or contraindications to undergo the investigated intervention (including brain MRI in the patient groups),
Clinically significant concomitant diseases such neurodegenerative disorders (e.g. Alzheimer's disease, Parkinson's disease)
Trial design
Design model
Single group
Treatments tested in this trial
video-oculography
Diagnostic testAll participants will receive quantitative oculomotor and pupillomotor measurements using two different video-oculography devices. Thereby both pursuit eye movements, saccades and pupillary responses to light will be assessed. In addition, there will be a quantitative assessment of the angular vestibulo-ocular reflex (aVOR) by use of video-head-impulse testing and a hearing test.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Oculomotor and pupillomotor quantitative measurementsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Accuracy in visually-guided saccades in patients with AVS
As the primary end point of our interventional study, the investigators selected the diagnostic accuracy of horizontal and vertical visually-guided saccades (calculated gain, looking for hypermetria and hypometria) in patients with either central or peripheral AVS (time points: acutely, at 3-month follow-up) and in comparison to healthy controls. Differences in quantitative saccade responses in the distinct study groups will support their future use in the acute evaluation of such patients in the ED and will help guide the ED physician in the selection of tests and their interpretation. In the secondary end points (see below), the investigators will also address to which extent the combination of quantitative oculomotor parameters may improve diagnostic accuracy.
Time frame
Two sessions will be recorded 3 months apart. For patients, session 1 will be obtained within 5 days after symptom onsetSecondary outcomes
1
Diagnostic accuracy for HINTS+ vs. brain MRI-DWI for detecting central AVS cases
Here the investigators will compare the diagnostic accuracy (sensitivity, specificity, NLR, PLR) of the HINTS+ score vs. brain MRI-DWI for detecting central (mostly ischemic) AVS causes. This comparison is thus between a bedside clinical score and imaging.
Time frame
One measurement in all AVS patients within 5 days of symptom-onset2
Diagnostic accuracy in pursuit eye movements in AVS patients for predicting a central origin
For this secondary aim, quantitative pursuit eye movement measurements (both in the horizontal and vertical) plane obtained within 5 days after symptom onset in the AVS patients are obtained and their diagnostic value for distinguishing between peripheral and central AVS cases is evaluated. For comparison, the same measurements will also be obtained in healthy controls.
Time frame
Two sessions will be recorded 3 months apart. For patients, session 1 will be obtained within 5 days after symptom onset3
Pupillary constriction to light (gain)
Pupillary constriction to bright light is assessed by use of the PRET video-oculography device, comparing findings in AVS patients and healthy controls. Diagnostic accuracy for detecting central AVS cases will be determined based on the pupillary response.
Time frame
Two sessions will be recorded 3 months apart. For patients, session 1 will be obtained within 5 days after symptom onset4
Diagnostic accuracy of a combined oculomotor-pupillomotor score vs. HINTS+
Here a combined oculomotor-pupillomotor score (gain of saccades, gain of pursuit and pupillary gain) is compared agains an established bedside evaluation (HINTS+). Specifically, the diagnostic accuracy of both scores for detecting an underlying central cause of the patient's AVS is calculated.
Time frame
Two sessions will be recorded 3 months apart. For patients, session 1 will be obtained within 5 days after symptom onsetLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Alexander Tarnutzer
Lead sponsor
Kantonsspital Baden
Sponsor institution
Source ClinicalTrials.gov
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