Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Vestibular Schwannoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02415257
• Other study ID #: VS-FT-02
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Vestibular schwannoma advised to surgical treatment

• No measurable remaining vestibular function

Exclusion Criteria:

• impaired decision making

• neurofibromatosis

• signs for central dysfunction

• remaining vestibular function

• Patients are advised not to participate in the gentamicin arm if

• hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70%

• the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Drug:
• Gentamicin
Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Locations

Country	Name	City	State
Sweden	Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjö P, Tjernström F. Vestibular "PREHAB". Ann N Y Acad Sci. 2009 May;1164:257-62. doi: 10.1111/j.1749-6632.2009.03778.x. — View Citation

Magnusson M, Kahlon B, Karlberg M, Lindberg S, Siesjö 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 — View Citation

Magnusson M, Karlberg M, Tjernström 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. — View Citation

Magnusson M, Padoan S. Delayed onset of ototoxic effects of gentamicin in treatment of Menière's disease. Rationale for extremely low dose therapy. Acta Otolaryngol. 1991;111(4):671-6. — View Citation

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. — View Citation

Tjernström F, Fransson PA, Kahlon B, Karlberg M, Lindberg S, Siesjö 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/jn — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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)
Secondary	Change of hearing levels	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
Secondary	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
Secondary	Differences of subjective well being after surgery	Daily subjective assessment of perceived vertigo/dizziness after surgery	Immediate time after surgery (2weeks)
Secondary	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
Secondary	Differences of subjective well being after gentamicin treatment	Daily subjective assessment of perceived vertigo/dizziness after gentamicin treatment	Immediate time after gentamicin treatment (2weeks)
Secondary	Differences of perceived dizziness after surgery	Measurement of level of dizziness in daily life, questionnaire Dizziness Handicap Inventory (DHI)	6 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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