Clinical Trial: Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

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

Official Title: Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable 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 vestibular function prior to surgery, even if vestibular function is absent according to modern assessment techniques

Detailed Summary: Patients subjected to vestibular schwannoma surgery most often suffer from vertigo after surgery, even if no vestibular function can be found in pre-surgical assessment. According to retrospective data about 33% of patients scheduled for surgery do not have any measurable vestibular function. Even the occurrence of spontaneous nystagmus has been recorded in patients with no or very little function prior to surgery (Parietti-Winkler et al. 2008 JNNP). This indicates that despite new methods of measuring vestibular function, remaining vestibular function can be present and patients might benefit from pre-treatment of gentamicin (Tjernström et al. 2009 JNNP)
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:

  • Occurrence of spontaneous nystagmus after surgery [ Time Frame: Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks) ]
    To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage
  • Change of hearing levels [ Time Frame: At first vestibular assessment and 4weeks after gentamicin installation ]
    Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects 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 ]
    Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital
  • Differences of subjective well being after surgery [ Time Frame: Immediate time after surgery (2weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after surgery
  • Differences of duration of hospital stay [ Time Frame: After surgery for the duration of the hospital stay up to 2 weeks ]
    Length of hospital stay required before patients can be discharged
  • Differences of subjective well being after gentamicin treatment [ Time Frame: Immediate time after gentamicin treatment (2weeks) ]
    Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
  • Differences of perceived dizziness after surgery [ Time Frame: 6 months after surgery ]
    Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
  • Differences of perceived anxiety/depression after surgery [ Time Frame: 6 months after surgery ]
    Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
  • Change of level of perceived dizziness after surgery as compared to before surgery [ Time Frame: At first vestibular assessment (inclusion) and 6 months after surgery ]
    Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)
  • Change of level of perceived anxiety/depression after surgery as compared to before surgery [ Time Frame: At first vestibular assessment (inclusion) and 6 months after surgery ]
    Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)
  • Differences in vestibular compensation after surgery [ Time Frame: 6 months after surgery ]
    Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery
  • Change of vestibular function after gentamicin treatment [ Time Frame: 6 weeks after gentamicin treatment ]
    Vestibular function tests; v-HIT (head impulse test), 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 26, 2015
Date Started: April 2015
Date Completion: December 2020
Last Updated: September 6, 2016
Last Verified: September 2016