Mapping of Vestibular Centers Activation Using fMRI in Patients With Vestibular Schwannoma

NCT07130851 | Active Not Recruiting

• 1 other identifier: EK-279.4/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is there a difference in the proces sof activation of vestibular centers in patients with unilateral vestibular disorder and healthy subjects.
2. 2.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.

Conditions

Vestibular Schwannoma; Unilateral Vestibular Deficit; Healthy

Keywords

vestibular centers; functional magnetic resonance; vestibular schwannoma; central compensation

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and one week

Secondary Outcomes (2)

• Change in cortical activation in response to acute onset of vestibular loss

  baseline and one week

• Possible influence of vestibular training in virtual reality environment on the rate of vestibular center activation

  baseline and 3 months

Study Arms (2)

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,..)

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,..)

Interventions

vestibular schwannoma resection PROCEDURE

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.

Vetibular schwannoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• vestibular schwannoma

You may not qualify if:

• claustrophobia, visual impairment

Sponsors & Collaborators

• Marketa Bonaventurova: lead

Study Sites (1)

Department of Otorhinolaryngology and Head and Neck Surgery, 1st Medical Faculty Charles University and University Hospital Motol

Prague, 150 06, Czechia

Location

Related Publications (2)

• 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.

  PMID: 19645932 BACKGROUND

• Helmchen 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.

  PMID: 20802221 BACKGROUND

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: August 19, 2025
• Study Start: June 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CZ (1)