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临床试验/NCT02773277
NCT02773277已完成不适用

Prospective Assessment of Peripheral-vestibular Function After Skull Base Surgery

University of Zurich0 个研究点目标入组 10 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
gain of the angular vestibulo-ocular reflex

研究概览

简要总结

Due to its localization in the cerebello-pontine angle, the vestibulo-cochlear nerve is at risk to damage during surgery performed nearby. In most cases, peripheral-cochleovestibular hypofunction recovers over the following weeks as the mechanism of damage is rather demyelination than axonal damage. The rate, intensity and extent of recovery of such perioperative peripheral-vestibular damage is not known.

详细描述

Due to its localization in the cerebello-pontine angle, the vestibulo-cochlear nerve is at risk to damage during surgery performed nearby, e.g. when removing an epidermoid cyst, treating a neuro-vascular conflict of the trigeminal nerve or resecting a petroclival meningeoma. Intense vertigo and dizziness accompanied by spontaneous nystagmus following Alexander's law, nausea and gait imbalance may be noted in these patients along with cochlear hypofunction (hearing loss). In most cases, peripheral-cochleovestibular hypofunction recovers over the following weeks as the mechanism of damage is rather demyelination than axonal damage. The rate, intensity and extent of recovery of such perioperative peripheral-vestibular damage is not known. Besides peripheral-vestibular hypofunction, transient cerebellar hypofunction may arise, presenting with similar complaints (vertigo, nausea, gait imbalance), however, distinct subtle ocular motor findings.

The aim of this study is to characterize the frequency and pattern of iatrogenic peripheral-vestibular and cochlear hypofunction and to follow-up on the speed and extent of recovery. The investigators hypothesize that peripheral-vestibular and cochlear damage may be observed in a significant fraction of neurosurgical treatments in the posterior fossa including the cerebello-pontine angle. While initially deficits may be major, recovery is expected to be substantial or even complete due to peripheral restoration. As an important differential diagnosis, the investigators will evaluate also for potential (transient) cerebellar loss of function.

In order to quantify peripheral-vestibular function the investigators will use a CE-certified videooculography device to record responses to the head-impulse test before and in the days following elective skull base surgery. the video-head impulse test (vHIT) allows a quantitative video-based assessment of the functional integrity of all semicircular canals (MacDougall et al. 2013). By use of a high-speed video-camera mounted on goggles this test quantifies the vestibulo-ocular reflex (VOR), which is the fastest human reflex and allows the recognition and visual fixation of objects while head turns or ambulation. This test is used on a routine basis in our clinic and includes brief and fast, but small amplitude head turns (10-15° excursion) in the planes of the different semi-circular canals (SCCs). The SCCs are tested in three pairs in the horizontal, RALP (right anterior, left posterior) and LARP (left anterior, right posterior) plane (Weber et al. 2008). During testing the participant is asked to fixate a visual target straight ahead. Duration of this test: about 15 minutes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • aged 18 years or older
  • informed consent
  • absence of exclusion criteria

排除标准

  • peripheral-vestibular deficit before surgery
  • disturbed consciousness
  • diagnosis of vestibular schwannoma
  • other neurological or systemic disorder which can cause dementia or cognitive dysfunction
  • known neck pain or status post neck trauma

结局指标

主要结局

gain of the angular vestibulo-ocular reflex

时间窗: comparison before surgery and up to 30 days post surgery

in all patients the mean gain for each semicircular canal will be determined

Cumulative saccade amplitudes per trial [°/trial] of the angular vestibulo-ocular reflex

时间窗: comparison before surgery and up to 30 days post surgery

in all patients the cumulative saccade amplitudes per trial for each semicircular canal will be determined

次要结局

  • clinical testing for skew deviation by use of the alternating cover test(comparison before surgery and up to 30 days post surgery)
  • clinical testing of the horizontal head-impulse test(comparison before surgery and up to 30 days post surgery)
  • clinical testing for gaze-evoked nystagmus(comparison before surgery and up to 30 days post surgery)

研究者

申办方类型
Other
责任方
Sponsor

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