Vestibular SchwannomaNCT07130851
Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma
A study testing vestibular schwannoma resection in people with Vestibular Schwannoma and Unilateral Vestibular Deficit, run by Marketa Bonaventurova at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to visualize the possible activation of vestibular centers in the brain using in patiens with unilateral vestibular damage, specifically in patients after vestibular schwannoma surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Schwannoma, Unilateral Vestibular Deficit, Healthy
- What is being tested?
- vestibular schwannoma resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2025to 20 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vestibular schwannoma
Who cannot join
- claustrophobia, visual impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zuzana Balatkova, MD, Ph.D. contact
Czechia1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology and Head and Neck Surgery, 1st Medical Faculty Charles University and University Hospital Motol
Prague, 150 06
Marketa Bonaventurova, MD, +420732766103, marketa.bonaventurova@fnmotol.cz
Zuzana Balatkova, MD, Ph.D., 604964657, zuzana.balatkova@fnmotol.cz
About this study
Official title: Mapping of Vestibular Center Activation Using fMRI in Patients With Vestibular Schwannoma
The goal of this clinical trial is to visualize the possible activation of vestibular centers in the brain using in patiens with unilateral vestibular damage, specifically in patients after vestibular schwannoma surgery.
The main questions it aims to answer are:
Read more
- Is there a difference in the proces sof activation of vestibular centers in patients with unilateral vestibular disorder and healthy subjects.
- Are we able to effect this activation with our postoperative treatment? Researchers will compare the obtained results between patients with unilateral vestibular disorder and healthy controls.
Participants will be asked to fill out the set of questionaires, to undergo clinical objective vestibular examnation and examination in magnetic resonance.
- Being tested
- vestibular schwannoma resection
- Keywords
- vestibular centers, functional magnetic resonance, vestibular schwannoma, central compensation
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular schwannoma resectionProcedure or surgery
Vestibular schwannoma resection leads to partial or combined acute unilateral peripheral or combined vestibular lesion.The organism responds with the process of central vestibular compensation.
| Study group | Role | What they receive |
|---|---|---|
| Vetibular schwannoma patients | Experimental | Patients with vestibular schwannoma undergoing surgical removal of the tumor one day before the surgery: objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, air calorics, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..) one week after the surgery: objective methods videoHead Impulse test, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..) Receives: Procedure: vestibular schwannoma resection |
| Healthy controls | No intervention | The healty patients without the history of vestibular disorder. objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, functional magnetic resonance subjective methods: questionnaires (DHI,..) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cortical vestibular center in acute unilateral vestibular lesion
Fuctional magnetic resonance (fMRI) could display certain areas of the brain and its pathways involved in the process of central compensation resulting from the acute unilateral vestibular lesion.
We aim to compare pre- and post- operative fMRI results with the results of healthy controls to see whether there is a difference in activating vestibular centers and maintaining the equilibrium after the central compensation occurs. Different level of activation of vestibular cortical areas, resp. differences in activation in response to optokinetic stimulation will be measured in healthy controls and study group. Evaluation of functional brain MRI will be provided by expert neuroradiologist. Vestibular function will be assessed by objective vestibular tests (videonystagmography, video Head Impuls Test) and by subjective scales (questionnaires - The Penn Acoustic Neuroma Quality-of-Life scale, Dizziness Handicap Inventory - in both the higher score indicates higher handicap).
Measured: baseline and one week
Secondary outcomes (2)
Change in cortical activation in response to acute onset of vestibular loss
Evaluation of differences between control and study group in functional brain MRI in response to wide field optokinetic stimulation. Differences in size and level of activation of vestibular cortical areas will be evaluated by expert neuroradiologist.
Measured: baseline and one week
Possible influence of vestibular training in virtual reality environment on the rate of vestibular center activation
The cohort group, which undergoes vestibular rehabilitation in virtual reality environment, will be evaluated and compared to control and study group. Functional brain MRI in response to wide field optokinetic stimulation will be evaluated by expert neuroradiologist.
The obtained data could serve as a basis for understanding the possibility of influencing the central compensation process and potentially, in the future, utilizing virtual reality as a tool for vestibular training.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marketa Bonaventurova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marketa Bonaventurova, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130851
- Sponsor's protocol ID
- EK-279.4/24
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication
Publications
Hufner K, Stephan T, Hamilton DA, Kalla R, Glasauer S, Strupp M, Brandt T. Gray-matter atrophy after chronic complete unilateral vestibular deafferentation. Ann N Y Acad Sci. 2009 May;1164:383-5. doi: 10.1111/j.1749-6632.2008.03719.x.
PubMed 19645932Helmchen C, Klinkenstein JC, Kruger A, Gliemroth J, Mohr C, Sander T. Structural brain changes following peripheral vestibulo-cochlear lesion may indicate multisensory compensation. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):309-16. doi: 10.1136/jnnp.2010.204925. Epub 2010 Aug 27.
PubMed 20802221
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of Vestibular Center Activation Using fMRI in Patients With Vestibular Schwannoma
- ClinicalTrials.gov ID
- NCT07130851
- Acronym / sponsor ID
- EK-279.4/24
- Keywords
- vestibular centers, functional magnetic resonance, vestibular schwannoma, central compensation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marketa BonaventurovaUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 20 Jun 2029 (estimated)
- First posted
- 19 Aug 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.
The goal of this clinical trial is to visualize the possible activation of vestibular centers in the brain using in patiens with unilateral vestibular damage, specifically in patients after vestibular schwannoma surgery.
The main questions it aims to answer are:
- Is there a difference in the proces sof activation of vestibular centers in patients with unilateral vestibular disorder and healthy subjects.
- Are we able to effect this activation with our postoperative treatment? Researchers will compare the obtained results between patients with unilateral vestibular disorder and healthy controls.
Participants will be asked to fill out the set of questionaires, to undergo clinical objective vestibular examnation and examination in magnetic resonance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vetibular schwannoma patients | Experimental | Procedure: vestibular schwannoma resectionPatients with vestibular schwannoma undergoing surgical removal of the tumor one day before the surgery: objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, air calorics, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..) one week after the surgery: objective methods videoHead Impulse test, clinical otoneurologic examination, functional magnetic resonance subjective methods: questionnaires (DHI,..) |
| Healthy controls | No intervention | –The healty patients without the history of vestibular disorder. objective methods videoHead Impulse test, cervical vestibular evoked myogenic potentials, functional magnetic resonance subjective methods: questionnaires (DHI,..) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- vestibular schwannoma
Key exclusion criteria (1 listed)
- claustrophobia, visual impairment
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 |
|---|---|---|
| vestibular schwannoma resectionVestibular schwannoma resection leads to partial or combined acute unilateral peripheral or combined vestibular lesion.The organism responds with the process of central vestibular compensation. | Procedure or surgery | Vetibular schwannoma patients |
Primary outcome
Identification of cortical vestibular center in acute unilateral vestibular lesion
Time frame: baseline and one week
Fuctional magnetic resonance (fMRI) could display certain areas of the brain and its pathways involved in the process of central compensation resulting from the acute unilateral vestibular lesion. We aim to compare pre- and post- operative fMRI results with the results of healthy controls to see whether there is a difference in activating vestibular centers and maintaining the equilibrium after the central compensation occurs. Different level of activation of vestibular cortical areas, resp. differences in activation in response to optokinetic stimulation will be measured in healthy controls and study group. Evaluation of functional brain MRI will be provided by expert neuroradiologist. Vestibular function will be assessed by objective vestibular tests (videonystagmography, video Head Impuls Test) and by subjective scales (questionnaires - The Penn Acoustic Neuroma Quality-of-Life scale, Dizziness Handicap Inventory - in both the higher score indicates higher handicap).
2 secondary outcomes
Change in cortical activation in response to acute onset of vestibular loss
Time frame: baseline and one week
Possible influence of vestibular training in virtual reality environment on the rate of vestibular center activation
Time frame: baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 19645932Hufner K, Stephan T, Hamilton DA, Kalla R, Glasauer S, Strupp M, Brandt T. Gray-matter atrophy after chronic complete unilateral vestibular deafferentation. Ann N Y Acad Sci. 2009 May;1164:383-5. doi: 10.1111/j.1749-6632.2008.03719.x.
- Results publication: PubMed 20802221Helmchen C, Klinkenstein JC, Kruger A, Gliemroth J, Mohr C, Sander T. Structural brain changes following peripheral vestibulo-cochlear lesion may indicate multisensory compensation. J Neurol Neurosurg Psychiatry. 2011 Mar;82(3):309-16. doi: 10.1136/jnnp.2010.204925. Epub 2010 Aug 27.
- Individual participant dataSharing planned: Yes. IPD used in the results publication
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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.
Zuzana Balatkova, MD, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular schwannoma resection in people with Vestibular Schwannoma and Unilateral Vestibular Deficit, run by Marketa Bonaventurova at 1 site in Czechia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marketa Bonaventurova, MD (+420732766103, marketa.bonaventurova@fnmotol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cortical vestibular center in acute unilateral vestibular lesion (time frame: baseline and one week). 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 NCT07130851, which also lists 2 linked publications.
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 22 Oct 2026.