Fact CheckerSign in

NCT06668857Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
75 (estimated)
First submitted
28 Oct 2024
Start date
1 Jul 2025
Primary completion date
1 Oct 2027
Lead sponsor
Alexander Tarnutzer
Diseases
Stroke
NCT number
NCT06668857

What you commit to

  • Study type: Interventional
  • Planned participants: 75
  • From 1 Jul 2025 to the primary completion date, 1 Oct 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Clinically significant concomitant diseases such neurodegenerative disorders (e.g. Alzheimer's disease, Parkinson's disease)

Other illness

  • History of brainstem / cerebellar stroke
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, aphasia.

Age

  • Aged less than 18 years.

Other

  • Pregnant or lactating women
  • Inability or contraindications to undergo the investigated intervention (including brain MRI in the patient groups),
  • Pre-existing peripheral-vestibular / central-vestibular deficits
  • Pre-existing or acute severe visual loss
  • Pre-existing severe hearing loss.

Who the study is looking for

  • Patient groups
    • patients presenting with an AVS (peripheral or central), with symptom duration of 5 days or less
    • being able to receive brain MRI
  • All groups:
    • Being able to give informed consent as documented by signature
    • Age 18 years or above

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.