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

Sponsor

University Hospital, Motol (Other)

Overall Status

Completed

CT.gov ID

NCT02963896

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Vestibular Schwannoma	Drug: gentamicin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gentamicin intratympanic application of gentamicin 0.5 ml	Drug: gentamicin intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml Other Names: gentamycin

Arm

Intervention/Treatment

Experimental: gentamicin

intratympanic application of gentamicin 0.5 ml

Drug: gentamicin

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

Other Names:

gentamycin

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Motol

Investigators

Principal Investigator: Zdeněk Čada, Ph.D., Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University in Prague and Motol University Hospital, Postgraduate Medical School