[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567489":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":35,"collaborators":20,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":20,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":20,"enrollmentInfo":49,"targetDuration":20,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":20},{"fullName":5,"class":6},"Kantonsspital Baden","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oculomotor and pupillomotor quantitative measurements","EXPERIMENTAL","The investigators will assess oculomotor and pupillomotor function at the bedside and quantitatively both in the acute stage (i.e., within the first 5 days after symptom onset on the ward) and again after 3 months at follow-up (in the outpatient center). They will measure visually-triggered saccadic eye movements and pursuit eye movements in the horizontal and vertical plane and assess pupillary responses to light. For comparison with established paradigms, they will also assess spontaneous nystagmus at primary gaze (with\u002Fwithout fixation), vertical ocular alignment on alternating cover test (looking for vertical deviations, termed skew deviation), gaze-evoked nystagmus on lateral gaze (GEN), and the horizontal head-impulse test (hHIT). The investigators will also test hearing. Bedside and quantitative testing will be performed at the same time.",[13],"Diagnostic Test: video-oculography",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","video-oculography","All 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.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Alexander A Tarnutzer, MD","Neurology, Cantonal Hospital of Baden, Baden, Switzerland","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+41564861610","alexander.tarnutzer@ksb.ch",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Maritta Spiegelberg, MD","+41564861615","maritta.spiegelberg@ksb.ch",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Alexander Tarnutzer","Senior leading physician","100567489","quantitative-eye-movement-measurements-in-patients-with-acute-vestibular-syndrome-100567489",false,"NCT06668857","Quantitative Eye Movement Measurements in Patients with Acute Vestibular Syndrome","Oculomotor Profile in Acute Vestibular Syndrome - Value of Saccades, Pursuit Eye Movements and Pupillary Reflexes in Differentiating Central and Peripheral Causes","Inclusion Criteria:\n\n* Patient groups\n\n  * patients presenting with an AVS (peripheral or central), with symptom duration of 5 days or less\n  * being able to receive brain MRI\n* All groups:\n\n  * Being able to give informed consent as documented by signature\n  * Age 18 years or above\n\nExclusion Criteria:\n\n* Aged less than 18 years.\n* Pregnant or lactating women\n* Inability or contraindications to undergo the investigated intervention (including brain MRI in the patient groups),\n* Clinically significant concomitant diseases such neurodegenerative disorders (e.g. Alzheimer's disease, Parkinson's disease)\n* Pre-existing peripheral-vestibular \u002F central-vestibular deficits\n* History of brainstem \u002F cerebellar stroke\n* Pre-existing or acute severe visual loss\n* Pre-existing severe hearing loss.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, aphasia.",true,"ALL","18 Years",{"count":50,"type":51},75,"ESTIMATED","INTERVENTIONAL",[54],"NA","BACKGROUND: A chief complaint of acute vertigo\u002Fdizziness 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.\n\nWORKING 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.\n\nAIM 1: Detecting changes in oculomotor and pupillomotor responses in acutely dizzy patients and characterizing the spectrum of abnormalities in peripheral and central AVS.\n\nAIM 2: Comparing different composite oculomotor-\u002Fpupillomotor scores to identify those scores with the highest diagnostic accuracy at the bedside and quantitatively.\n\nAIM 3: Comparing the diagnostic accuracy of bedside and quantitative oculomotor and pupillomotor testing in AVS- identifying potential limitations of bedside testing.\n\nMETHODS: 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.\n\nEXPECTED 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.",[57,58,59,60],"Acute Vestibular Syndrome","Vertigo","Stroke Acute","Acute Unilateral Vestibulopathy (AUV)",[62,63,64,65,66,67],"vertigo","dizziness","acute vestibular syndrome","stroke","vestibular neuritis","diagnostic accuracy","NOT_YET_RECRUITING","2024-10-30",{"date":71,"type":72},"2024-10-31","ACTUAL",{"date":74,"type":51},"2025-07-01",{"date":76,"type":51},"2028-06-30",{"name":37,"class":6}]