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

Not Applicable

Completed

• Conditions: Vestibular Schwannoma
• Interventions: Drug: gentamicin

• Registration Number: NCT02963896
• Lead Sponsor: University Hospital, Motol

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-11
• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-14
• Last Update Submitted: 2016-11-14
• Study First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gentamicin	gentamicin	intratympanic application of gentamicin 0.5 ml

Primary Outcome Measures

Name	Time	Method
The GBI questionnaire	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	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	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.