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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02963896
Acronym
ITG
Enrollment
20
Registered
2016-11-15
Start date
2014-01-31
Completion date
2015-12-31
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Schwannoma

Keywords

vestibular rehabilitation

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.

Interventions

DRUGgentamicin

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

Sponsors

University Hospital, Motol
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The GBI questionnaire2-3 yearsThe 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 questionnaire2-3 yearsThe 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 questionnaire2-3 yearsThe DHI contains 25 items and the range score is from 0 to +100, with a higher score indicating a more severe handicap.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026