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Prospective Assessment of Peripheral-vestibular Function After Skull Base Surgery

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ClinicalTrials.gov Identifier: NCT02773277
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Vestibular Other: head-impulse testing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: Single intervention arm
All patients will be assigned the intervention arm and will receive head-impulse testing before and in the days after skull base surgery.
Other: head-impulse testing
all patients will receive quantitative head impulse testing using video goggles for all six semicircular canals.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773277


Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Niklaus Krayenbühl, MD University Hospital Zurich, Neurology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02773277    
Other Study ID Numbers: vHIT_surgery
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No