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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gentamicin treated | Experimental | 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 |
|
| Non-gentamicin | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin | Drug | Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences and changes of postural control following surgery, compared to before surgery | Postural control assessed with posturography during a sensory conflict | At first vestibular assessment at the time for inclusion and 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of spontaneous nystagmus after surgery | To measure spontaneous nystagmus and its direction after surgery as a sign of vestibular deafferentation or central nervous damage | Day 1 after surgery and for the duration of either spontaneous nystagmus or hospital stay (up to 2 weeks) |
| Change of hearing levels |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of needed sick-leave from work and leisure activities | Time for return to normal daily activities after surgery, both job-related and leisure. | 6 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Tjernström, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital | Lund | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18676407 | Background | Parietti-Winkler C, Gauchard GC, Simon C, Perrin PP. Visual sensorial preference delays balance control compensation after vestibular schwannoma surgery. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1287-94. doi: 10.1136/jnnp.2007.135913. Epub 2008 Aug 1. | |
| 1950529 | Background | Magnusson M, Padoan S. Delayed onset of ototoxic effects of gentamicin in treatment of Meniere's disease. Rationale for extremely low dose therapy. Acta Otolaryngol. 1991;111(4):671-6. doi: 10.3109/00016489109138398. |
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| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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Measuring hearing levels (pure tone average and speech discrimination) before and after gentamicin treatment to determine possible detrimental effects on hearing |
| At first vestibular assessment and 4weeks after gentamicin installation |
| Differences in the level of stress after surgery | Measuring cortisol in the saliva after surgery during the time patients are admitted to the hospital | Daily after surgery for the duration of the hospital stay, up to 2 weeks |
| Differences of subjective well being after surgery | Daily subjective assessment of perceived vertigo/dizziness after surgery | Immediate time after surgery (2weeks) |
| Differences of duration of hospital stay | Length of hospital stay required before patients can be discharged | After surgery for the duration of the hospital stay up to 2 weeks |
| Differences of subjective well being after gentamicin treatment | Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment | Immediate time after gentamicin treatment (2weeks) |
| Differences of perceived dizziness after surgery | Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI) | 6 months after surgery |
| Differences of perceived anxiety/depression after surgery | Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS) | 6 months after surgery |
| Change of level of perceived dizziness after surgery as compared to before surgery | Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI) | At first vestibular assessment (inclusion) and 6 months after surgery |
| Change of level of perceived anxiety/depression after surgery as compared to before surgery | Measurement of level of anxiety/depression in daily life, questionnaire Hospital Anxiety and Depression Scale (HADS) | At first vestibular assessment (inclusion) and 6 months after surgery |
| Differences in vestibular compensation after surgery | Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after surgery | 6 months after surgery |
| Change of vestibular function after gentamicin treatment | Vestibular function tests; v-HIT (head impulse test), calorics and otolith tests to determine compensation and function after gentamicin treatment | 6 weeks after gentamicin treatment |
| 19574236 | Result | Tjernstrom F, Fransson PA, Kahlon B, Karlberg M, Lindberg S, Siesjo P, Magnusson M. Vestibular PREHAB and gentamicin before schwannoma surgery may improve long-term postural function. J Neurol Neurosurg Psychiatry. 2009 Nov;80(11):1254-60. doi: 10.1136/jnnp.2008.170878. Epub 2009 Jul 1. |
| 19645909 | Result | Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjo P, Tjernstrom F. Vestibular "PREHAB". Ann N Y Acad Sci. 2009 May;1164:257-62. doi: 10.1111/j.1749-6632.2009.03778.x. |
| 22027076 | Result | Magnusson M, Karlberg M, Tjernstrom F. 'PREHAB': Vestibular prehabilitation to ameliorate the effect of a sudden vestibular loss. NeuroRehabilitation. 2011;29(2):153-6. doi: 10.3233/NRE-2011-0689. |
| 17917842 | Result | Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjo P. Preoperative vestibular ablation with gentamicin and vestibular 'prehab' enhance postoperative recovery after surgery for pontine angle tumours--first report. Acta Otolaryngol. 2007 Dec;127(12):1236-40. doi: 10.1080/00016480701663433. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |