Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Not Applicable

Completed

• Conditions: Vestibular Function Disorder; Vestibular Schwannoma
• Interventions: Procedure: intratympanic application of gentamicin; Procedure: microsurgical removal of vestibular schwannoma

• Registration Number: NCT03638310
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

The aim of this study is to assess effect of psychiatric profile on visual sensitivity and overall health status in patients who underwent surgery for vestibular schwannoma and were prehabituated by chemical vestibular ablation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-05-08
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-17
• Last Update Submitted: 2018-08-17
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• T3, T4 vestibular schwannoma
• recorded growth of a tumour
• hearing loss greater than 50% in PTA

Exclusion Criteria

• T1 vestibular schwannomas
• no growth progression
• normal hearing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITG (intratympanic gentamicin) group	intratympanic application of gentamicin	Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.
control group	microsurgical removal of vestibular schwannoma	patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.
ITG (intratympanic gentamicin) group	microsurgical removal of vestibular schwannoma	Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.

Primary Outcome Measures

Name	Time	Method
change of optokinetic nystagmus measurement	change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention	During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention

Trial Locations

Locations (1)

Charles University; 🇨🇿 Prague, Czechia