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临床试验/NCT07130851
NCT07130851进行中(未招募)不适用

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

Marketa Bonaventurova2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
2
主要终点
Identification of cortical vestibular center in acute unilateral vestibular lesion

研究概览

简要总结

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

Participants will be asked to fill out the set of questionaires, to undergo clinical objective vestibular examnation and examination in magnetic resonance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • vestibular schwannoma

排除标准

  • claustrophobia, visual impairment

结局指标

主要结局

Identification of cortical vestibular center in acute unilateral vestibular lesion

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Marketa Bonaventurova
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marketa Bonaventurova

MD

Charles University, Czech Republic

研究点 (2)

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