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Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma

NCT ID: NCT02963896

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively.

Detailed Description

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Surgical removal of vestibular schwannoma causes acute vestibular symptoms, including postoperative vertigo and oscilopsia due to nystagmus. In general, the dominant symptom postoperatively is vertigo. Preoperative chemical vestibular ablation can reduce vestibular symptoms postoperatively. We used 1.0 ml of 40 mg/ml nonbuffered gentamicin in three intratympanic installations over 2 days, 2 months preoperatively in 10 patients. Reduction of vestibular function was measured by the head impulse test and the caloric test. Reduction of vestibular function was found in all gentamicin patient groups. After gentamicin vestibular ablation, patients underwent home vestibular exercising for two months. The control group consisted of 10 patients who underwent only home vestibular training two months preoperatively. Postoperative rate of recovery and vertigo in both groups were evaluated with the Glasgow Benefit Inventory (GBI), the Glasgow Health Status Inventory (GHSI) and the Dizziness Handicap Inventory questionnaires, as well as survey of visual symptoms by specific questionnaire developed by us.

Conditions

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Vestibular Schwannoma

Keywords

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vestibular rehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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gentamicin

intratympanic application of gentamicin 0.5 ml

Group Type EXPERIMENTAL

gentamicin

Intervention Type DRUG

intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml

Interventions

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gentamicin

intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml

Intervention Type DRUG

Other Intervention Names

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gentamycin

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of vestibular schwannoma
* hearing loss on affected side
* preserved vestibular reactivity of labyrinths on the affected side

Exclusion Criteria

* allergy to gentamicin
* vestibular areflexia on the affected side
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

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Zdeněk Čada

M.D., PH.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zdeněk Čada, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University in Prague and Motol University Hospital, Postgraduate Medical School

References

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Herdman SJ, Clendaniel RA, Mattox DE, Holliday MJ, Niparko JK. Vestibular adaptation exercises and recovery: acute stage after acoustic neuroma resection. Otolaryngol Head Neck Surg. 1995 Jul;113(1):77-87. doi: 10.1016/s0194-5998(95)70148-6.

Reference Type BACKGROUND
PMID: 7603726 (View on PubMed)

Cada Z, Balatkova Z, Chovanec M, Cakrt O, Hruba S, Jerabek J, Zverina E, Profant O, Fik Z, Komarc M, Betka J, Kluh J, Cerny R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8.

Reference Type DERIVED
PMID: 28053986 (View on PubMed)

Other Identifiers

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13476 FN Motol

Identifier Type: -

Identifier Source: org_study_id