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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital
Lund, Sweden
Differences and changes of postural control following surgery, compared to before surgery
Postural control assessed with posturography during a sensory conflict
Time frame: At first vestibular assessment at the time for inclusion and 6 months after surgery
Differences of duration of hospital stay
Hospital stay required before patients can be discharged
Time frame: After surgery for the duration of the hospital stay up to two weeks
Differences of subjective well being after surgery
Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment
Time frame: Immediate time after surgery (2 weeks)
Change of subjective well being after gentamicin treatment
Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment
Time frame: Immediate time after gentamicin installation (2 weeks)
Change of hearing levels
Measuring hearing levels (pure tone hearing and speech discrimination) before and after gentamicin treatment to determine possible detrimental effect on hearing
Time frame: At first vestibular assessment and 2 weeks after gentamicin installation
Differences in the level of stress after surgery
Daily Measures of cortisol in the saliva after surgery during the time patients are admitted to the hospital
Time frame: Daily after surgery for the duration of the hospital stay up to 2 weeks
Differences of perceived dizziness after surgery
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Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Time frame: 6 months after surgery
Differences of level of anxiety and depression
Measure of level of anxiety and depression after surgery, enquiry with Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months after surgery
Change of level of perceived dizziness after gentamicin
Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Time frame: At first vestibular assessment and 6 weeks after gentamicin installation
Differences of changes in levels of perceived dizziness after surgery as compared to before surgery
Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI)
Time frame: At first vestibular assessment and 6 months after surgery
Occurrence of spontaneous nystagmus after surgery
To measure spontaneous nystagmus after surgery and its direction as a sign of vestibular deafferentation or central nervous damage
Time frame: Day 1 after surgery and for duration of either spontaneous nystagmus or hospital stay (up to 2 weeks)
Differences in vestibular compensation after surgery
Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation after surgery
Time frame: 6 months after surgery
Change of vestibular function after gentamicin treatment
Vestibular function tests, v-HIT, calorics and otolith tests to determine compensation and function after gentamicin treatment
Time frame: 6weeks after gentamicin treatment