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Schwannoma

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Gentamicins

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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

Lund University

Symptoms and General Pathology

Behaviors and Mental Disorders

Vertigo

Dizziness

Vestibular Diseases

Labyrinth Diseases

Labyrinthitis

Neurologic Manifestations

Quality of Life

intratympanic application of gentamicin 0.5 ml

intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml

gentamicin

Zdeněk Čada, Ph.D.

Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively.

Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively. We used 1.0 ml of 40 mg/ml nonbuffered gentamicin in three intratympanic installations over 2 days, 2 months preoperatively in 10 patients. Reduction of vestibular function was measured by the head impulse test and the caloric test. Reduction of vestibular function was found in all gentamicin patient groups. After gentamicin vestibular ablation, patients underwent home vestibular exercising for two months. The control group consisted of 10 patients who underwent only home vestibular training two months preoperatively. Postoperative rate of recovery and vertigo in both groups were evaluated with the Glasgow Benefit Inventory (GBI), the Glasgow Health Status Inventory (GHSI) and the Dizziness Handicap Inventory questionnaires, as well as survey of visual symptoms by specific questionnaire developed by us.

Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma

Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma With Pretreatment Prehabituation by Chemical Vestibular Ablation

The GBI questionnaire consists of 18 questions. The response to each question is based on a five-point Likert scale, ranging from a large deterioration to a large improvement in health status. The GBI questionnaire is scored into a total score, and also three subscales: a general subscale (12 questions), a social support subscale (three questions), and a physical health subscale (three questions). Score ranges were calculated and varied from -100 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.

The GHSI questionnaire contains of 18 questions; again, the response to each question is based on a five-point Likert scale ranging from high to low health status. It is also scored into a total score and three subscales: general, social, and physical health subscales. All these scores range from 0 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.

The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function	NCT02415257	Vestibular Schw...	Gentamicin	18 Years -	Lund University
Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma	NCT02963896	Vestibular Schw...	gentamicin	-	University Hospital, Motol
Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma	NCT02963896	Vestibular Schw...	gentamicin	-	University Hospital, Motol
Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function	NCT02415257	Vestibular Schw...	Gentamicin	18 Years -	Lund University

Spots Global Cancer Trial Database for gentamicin

Every month we try and update this database with for gentamicin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gentamicin

Every month we try and update this database with for gentamicin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gentamicin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.