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Installation of gentamicin in the middle ear 6 weeks prior to surgery + rehabilitation exercises before and after both treatment and surgery.

Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board

Rehabilitation exercises before and after both treatment and surgery Rehabilitation exercises are not considered to be an intervention since their benign impact on vestibular/postural compensation is well documented and exclusion from exercises would not be approved by the ethical board

Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Gentamicin

Fredrik Tjernström, MD, PhD

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

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)

Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Gentamicin Treatment Prior to Vestibular Schwannoma Surgery in Patients With no Measurable Remaining Vestibular Function

Time for return to normal daily activities after surgery, both job-related and leisure.

Postural control assessed with posturography during a sensory conflict

To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage

Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing

Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital

Daily subjective assessment of perceived vertigo/dizziness after surgery

Length of hospital stay required before patients can be discharged

Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment

Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)

Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS)

Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery

Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function	NCT02415257	Vestibular Schw...	Gentamicin	18 Years -	Lund University
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function	NCT02415257	Vestibular Schw...	Gentamicin	18 Years -	Lund University

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