NCT03638310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

May 8, 2018

Last Update Submit

August 17, 2018

Conditions

Vestibular SchwannomaVestibular Function Disorder

Outcome Measures

Primary Outcomes (1)

  • change of optokinetic nystagmus measurement

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

    change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention

Study Arms (2)

ITG (intratympanic gentamicin) group

EXPERIMENTAL

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

Procedure: intratympanic application of gentamicinProcedure: microsurgical removal of vestibular schwannoma

control group

ACTIVE COMPARATOR

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

Procedure: microsurgical removal of vestibular schwannoma

Interventions

intratympanic application of gentamicinPROCEDURE

under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity

ITG (intratympanic gentamicin) group
microsurgical removal of vestibular schwannomaPROCEDURE

surgery under general anesthesia

ITG (intratympanic gentamicin) groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • T1 vestibular schwannomas
  • no growth progression
  • normal hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles University

Prague, 150 06, Czechia

Location

Related Publications (2)

  • 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.

    PMID: 28053986BACKGROUND

  • 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.

    PMID: 31796939DERIVED

MeSH Terms

Conditions

Neuroma, AcousticVestibular Diseases

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System DiseasesLabyrinth Diseases

Study Officials

  • Zdeněk čada, M.D., Ph.D.

    Charles university Prague

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zuzana Balatkova, M.D., Principal Investigator, Department of otorhinolaryngology and head and neck surgery,1st faculty of medicine Charles university and University hospital Motol, Prague, Head: Prof. Jan Plzak, M.D., Ph.D.

Study Record Dates

First Submitted

May 8, 2018

First Posted

August 20, 2018

Study Start

January 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 20, 2018

Record last verified: 2018-08

Locations

CZ(1)