Gentamicin Treatment Prior to Schwannoma Surgery - No Residual Function

NCT ID: NCT02415257

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2020-09-30

Brief 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

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)

Conditions

Vestibular Schwannoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Gentamicin treated

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

Group Type: EXPERIMENTAL

Gentamicin

Intervention Type: DRUG

Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Non-gentamicin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gentamicin

Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation

Intervention Type: DRUG

Other Intervention Names

prehabituation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredrik Tjernström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Dept. OtoRhinoLaryngology Head and Neck Surgery, Skane University Hospital

Lund, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 18676407 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1950529 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19574236 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19645909 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22027076 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17917842 (View on PubMed)

Other Identifiers

VS-FT-02

Identifier Type: -

Identifier Source: org_study_id