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Completed

NCT Number: NCT02773277

Prospective Assessment of Peripheral-vestibular Function After Skull Base Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

head-impulse testing

Other

all patients will receive quantitative head impulse testing using video goggles for all six semicircular canals.

Primary outcomes

  1. gain of the angular vestibulo-ocular reflex

    Time frame: comparison before surgery and up to 30 days post surgery

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

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

    Time frame: 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

Secondary outcomes

  1. clinical testing of the horizontal head-impulse test

    Time frame: comparison before surgery and up to 30 days post surgery

    besides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.

  2. clinical testing for gaze-evoked nystagmus

    Time frame: comparison before surgery and up to 30 days post surgery

    besides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.

  3. clinical testing for skew deviation by use of the alternating cover test

    Time frame: comparison before surgery and up to 30 days post surgery

    besides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 16, 2016
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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