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Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

Information source: Lund University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vestibular Schwannoma

Intervention: Gentamicin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Lund University

Official(s) and/or principal investigator(s):
Fredrik Tjernström, MD, PhD, Principal Investigator, Affiliation: Lund University

Overall contact:
Fredrik Tjernström, MD, PhD, Phone: +46 46 175849, Email: Fredrik.Tjernstrom@med.lu.se

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Differences and changes of postural control following surgery, compared to before surgery

Secondary outcome:

Occurrence of spontaneous nystagmus after surgery

Change of hearing levels

Differences in the level of stress after surgery

Differences of subjective well being after surgery

Differences of duration of hospital stay

Differences of subjective well being after gentamicin treatment

Differences of perceived dizziness after surgery

Differences of perceived anxiety/depression after surgery

Change of level of perceived dizziness after surgery as compared to before surgery

Change of level of perceived anxiety/depression after surgery as compared to before surgery

Differences in vestibular compensation after surgery

Change of vestibular function after gentamicin treatment

Detailed 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)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Fredrik Tjernström, MD, PhD, Phone: +46 46 175849, Email: Fredrik.Tjernstrom@med.lu.se

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital, Lund 22185, Sweden; Recruiting
Fredrik Tjernström, MD, PhD, Phone: +46 46 175849, Email: Fredrik.Tjernstrom@med.lu.se
Måns Magnusson, MD, PhD, Phone: +4646 171796, Email: Mans.Magnusson@med.lu.se
Additional Information

Related publications:

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.

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.

Starting date: April 2015
Last updated: April 8, 2015

Page last updated: August 23, 2015

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