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Clinical Trials/NCT02963896
NCT02963896
Completed
Not Applicable

Vertigo Perception and Quality of Life in Patients After Surgical Treatment of Vestibular Schwannoma With Pretreatment Prehabituation by Chemical Vestibular Ablation

University Hospital, Motol0 sites20 target enrollmentJanuary 2014
Interventionsgentamicin

Overview

Phase
Not Applicable
Intervention
gentamicin
Conditions
Vestibular Schwannoma
Sponsor
University Hospital, Motol
Enrollment
20
Primary Endpoint
The GBI questionnaire
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Motol
Responsible Party
Principal Investigator
Principal Investigator

Zdeněk Čada

M.D., PH.D.

University Hospital, Motol

Eligibility Criteria

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

Arms & Interventions

gentamicin

intratympanic application of gentamicin 0.5 ml

Intervention: gentamicin

Outcomes

Primary Outcomes

The GBI questionnaire

Time Frame: 2-3 years

The GBI questionnaire consists of 18 questions. The response to each question is based on a five-point Likert scale, ranging from a large deterioration to a large improvement in health status. The GBI questionnaire is scored into a total score, and also three subscales: a general subscale (12 questions), a social support subscale (three questions), and a physical health subscale (three questions). Score ranges were calculated and varied from -100 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.

The GHSI questionnaire

Time Frame: 2-3 years

The GHSI questionnaire contains of 18 questions; again, the response to each question is based on a five-point Likert scale ranging from high to low health status. It is also scored into a total score and three subscales: general, social, and physical health subscales. All these scores range from 0 to +100. Score all questions so that a score of 1 is given to the answer with the worst change in health status and 5 to the answer with the best change in health status.

The DHI questionnaire

Time Frame: 2-3 years

The DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.

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