NCT02773277

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

May 9, 2016

Last Update Submit

January 6, 2020

Conditions

Vestibular

Outcome Measures

Primary Outcomes (2)

  • gain of the angular vestibulo-ocular reflex

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

    comparison before surgery and up to 30 days post surgery

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

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

    comparison before surgery and up to 30 days post surgery

Secondary Outcomes (3)

  • 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

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

    comparison before surgery and up to 30 days post surgery

Study Arms (1)

Single intervention arm

EXPERIMENTAL

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

Interventions

head-impulse testingOTHER

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

Single intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or older
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Niklaus Krayenbühl, MD

    University Hospital Zurich, Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 16, 2016

Study Start

June 1, 2016

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

January 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share