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Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

Primary Purpose

Vestibular Schwannoma, Vestibular Function Disorder

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
intratympanic application of gentamicin
microsurgical removal of vestibular schwannoma
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Schwannoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charles University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ITG (intratympanic gentamicin) group

control group

Arm Description

Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.

patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.

Outcomes

Primary Outcome Measures

change of optokinetic nystagmus measurement
During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention

Secondary Outcome Measures

Full Information

First Posted
May 8, 2018
Last Updated
August 17, 2018
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT03638310
Brief Title
Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery
Official Title
Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma, Vestibular Function Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITG (intratympanic gentamicin) group
Arm Type
Experimental
Arm Description
Patients who underwent prehabituation by gentamicin prior to surgery for vestibular schwannoma. They underwent intratympanic application of gentamicin and microsurgical removal of vest. schwannoma.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.
Intervention Type
Procedure
Intervention Name(s)
intratympanic application of gentamicin
Intervention Description
under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity
Intervention Type
Procedure
Intervention Name(s)
microsurgical removal of vestibular schwannoma
Intervention Description
surgery under general anesthesia
Primary Outcome Measure Information:
Title
change of optokinetic nystagmus measurement
Description
During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention
Time Frame
change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zdeněk čada, M.D., Ph.D.
Organizational Affiliation
Charles university Prague
Official's Role
Study Chair
Facility Information:
Facility Name
Charles University
City
Prague
ZIP/Postal Code
150 06
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is planned to share the data concerning description of pathology (size of the tumour), outcomes of clinical examination- objective vestibular measures, outcomes of questionnaires (QoL, depression/anxiety scale)
Citations:
PubMed Identifier
28053986
Citation
Cada Z, Balatkova Z, Chovanec M, Cakrt O, Hruba S, Jerabek J, Zverina E, Profant O, Fik Z, Komarc M, Betka J, Kluh J, Cerny R. Vertigo Perception and Quality of Life in Patients after Surgical Treatment of Vestibular Schwannoma with Pretreatment Prehabituation by Chemical Vestibular Ablation. Biomed Res Int. 2016;2016:6767216. doi: 10.1155/2016/6767216. Epub 2016 Dec 8.
Results Reference
background
PubMed Identifier
31796939
Citation
Balatkova Z, Cada Z, Hruba S, Komarc M, Cerny R. Assessment of visual sensation, psychiatric profile and quality of life following vestibular schwannoma surgery in patients prehabituated by chemical vestibular ablation. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2020 Dec;164(4):444-453. doi: 10.5507/bp.2019.056. Epub 2019 Dec 3.
Results Reference
derived

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Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

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