VertigoNCT06848712
Brain Structural Abnormalities in Patients With Vertigo
An observational study of Vertigo and MRI, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 464 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years
- Reported dizziness (vertigo) as a primary symptom
- Brain MRI requested by the attending physician
Who cannot join
- Prior neurological disease or disorder (other than vertigo/dizziness in the vertigo group)
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Vertigo is a prevalent symptom with multiple underlying etiologies, including neurological, vascular, and musculoskeletal causes. Despite its high prevalence, the exact structural brain abnormalities associated with vertigo remain unclear. This observational study aims to assess brain MRI findings in patients with vertigo and compare them to a control group without vertigo symptoms. The study also evaluates pre-MRI diagnostic procedures, such as vertebral/carotid ultrasound and cervical spine X-rays, to identify potential vascular and musculoskeletal contributors to vertigo. The results may provide insights into the structural brain changes linked to vertigo and help refine diagnostic and treatment strategies.
- Being tested
- Observational Study - No intervention
- Keywords
- vertigo, MRI, white matter lesions, Circle of Willis, sinusitis, BPPV, lifestyle modifications, betahistine
- Medical subject headings
- Vertigo, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study - No interventionOther
This is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational Study - No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From September 2020 to December 2022
Secondary outcomes (4)
Occurrences of associated symptoms in vertigo patients
The study evaluated the occurrences of associated symptoms, including headache, imbalance, visual disturbances, and psychological symptoms (anxiety and depression). Each symptom's occurrences (number and percentage) will be reported separately.
Measured: From September 2020 to December 2022
Occurrences of pre-MRI diagnostic procedures in vertigo patients
The study assessed the occurrences of patients with vertigo undergoing pre-MRI diagnostic procedures, including carotid/vertebral ultrasound and cervical spine X-rays. Each procedure's occurrences (number and percentage) will be reported separately.
Measured: From September 2020 to December 2022
Occurrences of post-MRI diagnoses in vertigo patients
The study analyzed the most common diagnoses after MRI, including vestibular migraine, benign paroxysmal positional vertigo (BPPV), and vascular dizziness. Each diagnosis's occurrences (number and percentage) will be reported separately.
Measured: From September 2020 to December 2022
Occurrences of treatment strategies applied
The study evaluated the most frequent treatment strategies, including physical therapy, pharmacological treatment (e.g., betahistine), and lifestyle modifications. Each treatment's occurrences (number and percentage) will be reported separately.
Measured: From September 2020 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Klaudia Széphelyi, Principal investigator, University of Pécs, Faculty of Health Sciences, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848712
- Sponsor's protocol ID
- IG/296-1/2025/2
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41002934
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Structural Abnormalities in Patients With Vertigo
- ClinicalTrials.gov ID
- NCT06848712
- Acronym / sponsor ID
- IG/296-1/2025/2
- Keywords
- vertigo, MRI, white matter lesions, Circle of Willis, sinusitis, BPPV, lifestyle modifications, betahistine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vertigo is a prevalent symptom with multiple underlying etiologies, including neurological, vascular, and musculoskeletal causes. Despite its high prevalence, the exact structural brain abnormalities associated with vertigo remain unclear. This observational study aims to assess brain MRI findings in patients with vertigo and compare them to a control group without vertigo symptoms. The study also evaluates pre-MRI diagnostic procedures, such as vertebral/carotid ultrasound and cervical spine X-rays, to identify potential vascular and musculoskeletal contributors to vertigo. The results may provide insights into the structural brain changes linked to vertigo and help refine diagnostic and treatment strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertigo Group | – | Other: Observational Study - No interventionParticipants 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. |
| Control Group | – | Other: Observational Study - No interventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years
- Reported dizziness (vertigo) as a primary symptom
- Brain MRI requested by the attending physician
Key exclusion criteria (2 listed)
- Prior neurological disease or disorder (other than vertigo/dizziness in the vertigo group)
- MRI contraindications (e.g., pacemaker, metal implants, claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study - No interventionThis is an observational study evaluating brain structural abnormalities in post-COVID headache patients. No experimental intervention is applied. | Other | Control Group, Vertigo Group |
Primary outcome
Occurrences With Specific Structural Brain Abnormalities Observed on MRI
Time frame: From September 2020 to December 2022
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.
4 secondary outcomes
Occurrences of associated symptoms in vertigo patients
Time frame: From September 2020 to December 2022
Occurrences of pre-MRI diagnostic procedures in vertigo patients
Time frame: From September 2020 to December 2022
Occurrences of post-MRI diagnoses in vertigo patients
Time frame: From September 2020 to December 2022
Occurrences of treatment strategies applied
Time frame: From September 2020 to December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 41002934Szephelyi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaudia Széphelyi principal investigator
University of Pécs, Faculty of Health Sciences, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and MRI, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrences With Specific Structural Brain Abnormalities Observed on MRI (time frame: From September 2020 to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.