Clinical Trial: Gentamicin Treatment Prior to Schwannoma Surgery - Residual Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With Definite Remaining Vestibular Function

Brief Summary: The purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

Detailed Summary: The residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. An acute unilateral vestibular deafferentation (uVD) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. The nausea/vertigo induced by surgery and sudden uVD both can impede vestibular compensation processes and in extension, also the need for rehabilitation. The vestibular PREHAB protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. The protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uVD over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. Through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uVD.
Sponsor: Lund University

Current Primary Outcome: Differences and changes of postural control following surgery, compared to before surgery [ Time Frame: At first vestibular assessment at the time for inclusion and 6 months after surgery ]

Postural control assessed with posturography during a sensory conflict


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Differences of duration of hospital stay [ Time Frame: After surgery for the duration of the hospital stay up to two weeks ]
    Hospital stay required before patients can be discharged
  • Differences of subjective well being after surgery [ Time Frame: Immediate time after surgery (2 weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment
  • Change of subjective well being after gentamicin treatment [ Time Frame: Immediate time after gentamicin installation (2 weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
  • Change of hearing levels [ Time Frame: At first vestibular assessment and 2 weeks after gentamicin installation ]
    Measuring hearing levels (pure tone hearing and speech discrimination) before and after gentamicin treatment to determine possible detrimental effect on hearing
  • Differences in the level of stress after surgery [ Time Frame: Daily after surgery for the duration of the hospital stay up to 2 weeks ]
    Daily Measures of cortisol in the saliva after surgery during the time patients are admitted to the hospital
  • Differences of perceived dizziness after surgery [ Time Frame: 6 months after surgery ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
  • Differences of level of anxiety and depression [ Time Frame: 6 months after surgery ]
    Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)
  • Change of level of perceived dizziness after gentamicin [ Time Frame: At first vestibular assessment and 6 weeks after gentamicin installation ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
  • Differences of changes in levels of perceived dizziness after surgery as compared to before surgery [ Time Frame: At first vestibular assessment and 6 months after surgery ]
    Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
  • Occurrence of spontaneous nystagmus after surgery [ Time Frame: Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks) ]
    To measure spontaneous nystagmus after surgery and its direction as a sign of vestibular deafferentation or central nervous damage
  • Differences in vestibular compensation after surgery [ Time Frame: 6 months after surgery ]
    Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation after surgery
  • Change of vestibular function after gentamicin treatment [ Time Frame: 6weeks after gentamicin treatment ]
    Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation and function after gentamicin treatment


Original Secondary Outcome: Same as current

Information By: Lund University

Dates:
Date Received: January 25, 2015
Date Started: January 2015
Date Completion: December 2018
Last Updated: September 6, 2016
Last Verified: September 2016