NCT06848712

Brief Summary

Introduction: Dizziness is one of the most common complaints in medical practice and is associated with various underlying conditions, including neurological, otolaryngological, and psychological disorders. Preliminary imaging studies like CT, cervical spine X-rays, and carotid/vertebral artery ultrasound, aids in precise diagnosis and targeted therapeutic decisions. MRI is one of the most effective imaging modalities currently available for examining the brain. Purpose: To identify structural brain changes linked to vertigo, explore pre-MRI diagnostic approaches, and evaluate treatment strategies. Methods: The study included 232 patients with vertigo and 232 control subjects. MRI results were categorized, and pre-MRI examinations, symptoms, and treatments were analyzed. Statistical comparisons were conducted using chi-square and t-tests, with significance set at p\<0.05.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

February 11, 2025

Last Update Submit

February 22, 2025

Conditions

Keywords

vertigoMRIwhite matter lesionsCircle of WillissinusitisBPPVlifestyle modificationsbetahistine

Outcome Measures

Primary Outcomes (1)

  • Occurrences With Specific Structural Brain Abnormalities Observed on MRI

    Brain MRI findings were analyzed to compare the occurrences of structural abnormalities between vertigo patients and control participants. The most commonly assessed abnormalities included white matter lesions, lacunar infarcts, Circle of Willis variations, and sinusitis. The occurrences (number and percentage) of these findings in each group will be compared using chi-square tests.

    From September 2020 to December 2022

Secondary Outcomes (4)

  • Occurrences of associated symptoms in vertigo patients

    From September 2020 to December 2022

  • Occurrences of pre-MRI diagnostic procedures in vertigo patients

    From September 2020 to December 2022

  • Occurrences of post-MRI diagnoses in vertigo patients

    From September 2020 to December 2022

  • Occurrences of treatment strategies applied

    From September 2020 to December 2022

Study Arms (2)

Vertigo Group

Participants in this group reported dizziness as a primary symptom and were referred for brain MRI to investigate potential structural abnormalities. Exclusion criteria included any pre-existing neurological disorders. The most common diagnoses after MRI included benign paroxysmal positional vertigo (BPPV) and vertebrobasilar syndrome.

Other: Observational Study - No intervention

Control Group

Participants in this group did not report dizziness or other neurological symptoms. They underwent brain MRI for other reasons but had no history of neurological disorders. This group served as a comparison to evaluate the prevalence of brain structural abnormalities in vertigo patients.

Other: Observational Study - No intervention

Interventions

This is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied.

Control GroupVertigo Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adult patients (≥18 years) with vertigo who were referred for brain MRI to investigate potential structural abnormalities. A control group of individuals without a history of vertigo or neurological disorders was included for comparison. Exclusion criteria included prior neurological diseases, recent head trauma, and MRI contraindications.

You may qualify if:

  • Age ≥18 years
  • Reported dizziness (vertigo) as a primary symptom
  • Brain MRI requested by the attending physician

You may not qualify if:

  • Prior neurological disease or disorder (other than vertigo/dizziness in the vertigo group)
  • MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szent Margit Hospital

Budapest, 1032, Hungary

Location

Related Publications (1)

  • Szephelyi K, Kora S, Orsi G, Tollar J. Structural Brain Abnormalities, Diagnostic Approaches, and Treatment Strategies in Vertigo: A Case-Control Study. Neurol Int. 2025 Sep 10;17(9):146. doi: 10.3390/neurolint17090146.

MeSH Terms

Conditions

VertigoSinusitis

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract Diseases

Study Officials

  • Klaudia Széphelyi

    University of Pécs, Faculty of Health Sciences, Hungary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 27, 2025

Study Start

September 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations