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Prospective Assessment of Peripheral-vestibular Function After Skull Base Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02773277
Enrollment
10
Registered
2016-05-16
Start date
2016-06-01
Completion date
2019-05-31
Last updated
2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular

Brief summary

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.

Detailed description

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.

Interventions

OTHERhead-impulse testing

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

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. aged 18 years or older 2. informed consent 3. absence of

Design outcomes

Primary

MeasureTime frameDescription
gain of the angular vestibulo-ocular reflexcomparison before surgery and up to 30 days post surgeryin all patients the mean gain for each semicircular canal will be determined
Cumulative saccade amplitudes per trial [°/trial] of the angular vestibulo-ocular reflexcomparison before surgery and up to 30 days post surgeryin all patients the cumulative saccade amplitudes per trial for each semicircular canal will be determined

Secondary

MeasureTime frameDescription
clinical testing of the horizontal head-impulse testcomparison before surgery and up to 30 days post surgerybesides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.
clinical testing for gaze-evoked nystagmuscomparison before surgery and up to 30 days post surgerybesides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.
clinical testing for skew deviation by use of the alternating cover testcomparison before surgery and up to 30 days post surgerybesides the vHIT, patients will be examined clinically, including testing for central-type acute vestibular syndrome.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026