Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks. (UTRAVERA)

The UTRAVERA: a Multicenter Prospective Observational Investigation on Vertigo and Dizziness Due to Vertebrobasilar Transient Neurological Attacks - Diagnoses, Clinical Features, Treatment Responses, and Prognostic Factors.

Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Distinguishing VB-TNAs, particularly vertebrobasilar transient ischemic attacks (VB-TIAs), from migraine-like and other non-vascular conditions is often challenging at first presentation due to the absence of specific biomarkers and overlapping clinical features. The UTRAVERA study is a multicenter, prospective, observational investigation designed to characterize the clinical features of patients presenting with acute transient vertigo or dizziness suspected to be VB-TNAs. The study will also evaluate diagnostic evolution over time, treatment responses, and prognostic factors associated with clinical outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Vertigo; Dizziness; TIA (Transient Ischemic Attack); Transient Neurologic Symptoms

Detailed Description

The UTRAVERA (Unclassified Transient Vertiginous Attacks) study is a multicenter, prospective, observational cohort study designed in accordance with the SPIRIT 2025 Statement. The study aims to address diagnostic uncertainty in patients presenting to the emergency department with acute transient vertigo, dizziness, or unsteadiness lasting less than 24 hours, with no immediate evidence of stroke on neuroimaging.

The study focuses on the spectrum of vertebrobasilar transient neurological attacks (VB-TNAs), a clinical construct that encompasses transient vestibular symptoms with or without associated brainstem manifestations, such as diplopia, dysarthria, ataxia, sensory disturbances, or bilateral visual symptoms.

Initially, these episodes may be indistinguishable from vestibular migraine, atypical peripheral vestibular disorders, or other miscellaneous conditions, resulting in a diagnostic gray zone.

Adult patients presenting with transient vertigo or dizziness are prospectively enrolled and undergo standardized otologic, neurological, cardiovascular, and imaging evaluations, including diffusion-weighted MRI and vascular imaging of the vertebrobasilar circulation. Based on baseline findings and longitudinal follow-up, patients are classified into diagnostic categories, including VB-TIA, migraine-like disorder, miscellaneous causes, or unclassified attacks.

Follow-up assessments are performed at three and six months to evaluate diagnostic reclassification, symptom recurrence, treatment responses, and clinical outcomes. The study protocol does not mandate therapeutic interventions, which reflect standard clinical care, particularly antithrombotic strategies in patients suspected of VB-TIA.

The primary objectives of the study are to describe the clinical characteristics of VB-TNAs, assess the accuracy of the initial diagnostic classification over time, evaluate therapeutic outcomes, and identify prognostic factors associated with adverse events.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: ARLINDO C NETO, PhD; Phone Number: +5515996928584; Email: aclimanetoent@gmail.com
• Study Contact Backup: Name: Ji-Soo Kim, PhD; Phone Number: +82 31 787 7463; Email: jisookim@snu.ac.kr

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403900
      • Hospital das Clínicas - University of São Paulo
      • Contact: ARLINDO C NETO, PhD; Phone Number: +5515996928584; Email: aclimanetoent@gmail.com
      • Contact: Ji-Soo Kim, PhD; Phone Number: +82 31 787 7463; Email: jisookim@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults presenting with acute or transient episodes of vertigo, dizziness, or unsteadiness that suggest vertebrobasilar transient neurological attacks will be evaluated in emergency departments or outpatient neurotology/neurology settings. Participants will be prospectively enrolled based on predefined clinical criteria and followed longitudinally to assess diagnostic confirmation, clinical characteristics, treatment responses, and prognostic outcomes.

Description

Inclusion Criteria:

• Episodic acute vertigo, dizziness or unsteadiness transient or in evolution, therefore, lasting <24 h

• Such an episode may be isolated or associated with one or more of the following:

  1. focal central neurological symptoms or severe postural instability;
  2. new-onset, moderate-to-severe craniocervical pain; or
  3. symptoms that are not better accounted for by another disease or disorder.

Exclusion Criteria:

• Patients who present with findings of acute hemorrhage or ischemia on the cranial magnetic resonance imaging (MRI), including diffusion-weighted MRI (DWI-MRI) at recruitment;
• Patients who also fulfill the diagnostic criteria for other neurotological diseases that may present acute or recurrent transient dizziness/Vertigo (Unilateral Vestibulopathy; benign paroxysmal positional vertigo; Meniére's disease; Vestibular Migraine; Vestibular Paroxysmia; Persistente Postural-Perceptual Dizziness; and Postural Hypotension;
• Patients whose symptoms last more than 24 hours or who have evidence of sequelae during follow-up;
• Patients with contraindications to any of the therapeutic options proposed by this study method;
• Patients who have other symptoms during the follow-up that suggest another etiology of dizziness or vertigo;
• Patients who do not complete the entire evaluation;
• Patients who refuse to sign the informed consent form.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
VB-TIA; Patients who experience TNAs due to a probable vascular cause and who meet one of the following criteria: (a) increased risk for vascular events, for example, ABCD2 score of 4 or greater or atrial fibrillation; (b) significant (>50%) narrowing of an artery in the vertebrobasilar (VB) system; (c) significant arterial hypoplasia or dolichoectasia; (d) an arterial malformation that favors ischemic events; and (e) isolated spontaneous episodic vertigo/dizziness in older adults with no other possible causes.
Migraine-like Disorder; Aplied in patients with no cardiovascular risk profile, and TNAs associated to one of the following: (a) evidence of migraine in previous history, or during the follow-up; (b) current headache that fulfils migraine criteria; (c) current or previous symptoms of motion sickness.
Miscellaneous; Comprise different diagnoses such as hypertensive crisis, functional attacks, atipical BPPV, and rare central disorders such as multiple sclerosis, tumors, or encephalitis.
Unclassified; Patients who do not fullfil any of the previous, and have symptom constellations that are not characteristic of any distinct etiology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA)	The proportion of patients for whom the initial clinical diagnosis of vertebrobasilar transient neurological attacks is confirmed or revised during follow-up based on clinical reassessment, neuroimaging, and a multidisciplinary evaluation.	Up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with ischemic stroke or death during 12-month follow-up.	The number of enrolled participants who experienced an ischemic stroke (clinically diagnosed and/or confirmed by neuroimaging) or died from any cause during the 12 months following the index event.	Up to 12 months
Number of participants with recurrence of transient neurological or vestibular symptoms during 12-month follow-up.	The number of participants who reported new episodes of transient focal neurological or vestibular symptoms during the 12-month follow-up period after the index event.	Up to 12 months.
Number of participants with change in diagnostic classification between baseline and 12 months.	The number of participants whose final diagnosis at 12 months differs from their initial classification (e.g., vertebrobasilar transient neurological attack, vestibular migraine, other causes, or unclassified).	Up to 12 months.
Number of participants with death, ischemic stroke, or recurrent vertebrobasilar transient neurological attack during 12-month follow-up among participants with final diagnosis of VB-TIA receiving prescribed treatment.	The number of participants in the VB-TIA subgroup who experienced any of the following during follow-up after initiation of the prescribed treatment following the index event: death from any cause,; stroke (clinically diagnosed and/or confirmed by neuroimaging), or; recurrent TNA event (a new episode meeting the study's predefined VB-TNA criteria).	Up to 12 months.

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: University of Zurich; University College, London; Seoul National University Bundang Hospital; LMU Klinikum
• Investigators: Study Chair: Ji-Soo Kim, PhD, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Kim, J. S., Newman-Toker, D. E., Kerber, K. A., Jahn, K., Bertholon, P., Waterston, J., ... & Strupp, M. (2022). Vascular vertigo and dizziness: Diagnostic criteria: consensus document of the committee for the classification of vestibular disorders of the Bárány society. Journal of Vestibular Research, 32(3), 205-222.
• Filippopulos, F. M., Strobl, R., Belanovic, B., Dunker, K., Grill, E., Brandt, T., et al. (2022). Validation of a comprehensive diagnostic algorithm for patients with acute vertigo and dizziness. Eur. J. Neurol. 29, 3092-3101. doi: 10.1111/ ene.15448
• Edlow, J. A., Carpenter, C., Akhter, M., Khoujah, D., Marcolini, E., Meurer, W.J., et al. (2023). Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): acute dizziness and vertigo in the emergency department. Acad. Emer. Med. 30, 442-486. doi: 10.1111/acem.14728
• Tuna, M. A., & Rothwell, P. M. (2021). Diagnosis of non-consensus transient ischaemic attacks with focal, negative, and non-progressive symptoms: population-based validation by investigation and prognosis. The Lancet, 397(10277), 902-912.
• Neto, A. C. L., Kim, J. S., Bernardo, W. M., & Bittar, R. S. M. (2024). Vertigo and dizziness due to vertebrobasilar TIA: a prospective study. Frontiers in Stroke, 3, 1429068.
• Cortese, E., Rochelle, P. L., Patel, F., Koohi, N., & Kaski, D. (2025). Integrated diagnostic algorithm for acute vertigo combining TiTrATE, STANDING, and HINTS: a validation study in the emergency department. Scientific Reports, 15(1), 25403.
• Kleindorfer, D. O., Towfighi, A., Chaturvedi, S., Cockroft, K. M., Gutierrez, J., Lombardi-Hill, D., ... & Williams, L. S. (2021). 2021 guideline for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline from the American Heart Association/American Stroke Association. Stroke, 52(7), e364-e467.Strupp M, Magnusson M. Acute unilateral vestibulopathy. Neurol Clin. 2015;33(3):669-685.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Emergency Department; Diagnostic Accuracy; TIA; Prognostic Factors; vertigo and dizziness; Vertebrobasilar Transient Neurological Attack; Vestibular Symptom
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Brain Ischemia; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Labyrinth Diseases; Vestibular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ischemic Attack, Transient; Emergencies; Vertigo; Dizziness
• Other Study ID Numbers: UTRAVERA-HCFMUSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in publications, including demographic, clinical, imaging-derived categorical variables, and outcome measures.
• IPD Sharing Time Frame: Individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years thereafter.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a methodologically sound proposal addressing research questions consistent with the objectives of the UTRAVERA study. Requests will be reviewed by the study steering committee. Data access will be provided following approval and execution of a data use agreement.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No