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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.
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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 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 |
|---|---|---|---|---|
| Gentamicins | 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 |
|---|---|---|
| Differences of duration of hospital stay | Hospital stay required before patients can be discharged | After surgery for the duration of the hospital stay up to two weeks |
| Differences of subjective well being after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of needed sick-leave from work and leisure activities | Time to return to normal daily activities after surgery, both job-related and leisure activities | 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 |
|---|---|---|---|
| 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. | |
| 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. |
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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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Daily subjective assessment of perceived vertigo/dizziness after surgery and gentamicin treatment
| Immediate time after surgery (2 weeks) |
| Change of subjective well being after gentamicin treatment | Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment | 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 | 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 | Daily after surgery for the duration of the hospital stay up to 2 weeks |
| Differences of perceived dizziness after surgery | Measure of level of impact of dizziness in daily life, measured with Dizziness Handicap Inventory (DHI) | 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) | 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) | 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) | 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 | 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 | 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 | 6weeks after gentamicin treatment |
| 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. |
| 18607963 | Result | Postema RJ, Kingma CM, Wit HP, Albers FW, Van Der Laan BF. Intratympanic gentamicin therapy for control of vertigo in unilateral Menire's disease: a prospective, double-blind, randomized, placebo-controlled trial. Acta Otolaryngol. 2008 Aug;128(8):876-80. doi: 10.1080/00016480701762458. |
| 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 |