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CompletedNCT03638310Updated Aug 20, 2018

Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

An interventional study of intratympanic application of gentamicin and microsurgical removal of vestibular schwannoma in Vestibular Schwannoma and Vestibular Function Disorder, sponsored by Charles University, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.

Sponsored by Charles University, Czech Republic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2016, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Vestibular Schwannoma
  • Vestibular Function Disorder
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In context

Neurilemmoma

82 studies on the registry are indexed under Neurilemmoma; 21 are open to participants now.

This study's enrollment of 37 is above the median of 21 across 47 interventional studies indexed under Neurilemmoma.

Browse Neurilemmoma studies →

Lead sponsor

Charles University, Czech Republic is the lead sponsor of 220 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • T1 vestibular schwannomas
  • no growth progression
  • normal hearing
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    ITG (intratympanic gentamicin) group

    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 gentamicin · Procedure: microsurgical removal of vestibular schwannoma

  • Active comparator
    control group

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

    Procedure: microsurgical removal of vestibular schwannoma

Interventions

  • Procedureintratympanic application of gentamicin

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

  • Proceduremicrosurgical removal of vestibular schwannoma

    surgery under general anesthesia

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What researchers measure

Primary outcomes

  1. change of optokinetic nystagmus measurement

    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

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Study locations

1 site
  • Charles University
    Prague, 150 06, Czechia
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References and documents

Publications

  • 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. PubMed 28053986 ↗
  • 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. PubMed 31796939 ↗

Individual participant data

Plan to share: Undecided — 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)

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03638310
Lead sponsor
Charles University, Czech Republic
Responsible party
Balatkova Zuzana (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., Charles University, Czech Republic) — Principal investigator
First posted
Aug 20, 2018
Start date
Jan 1, 2016
Primary completion
Jun 1, 2018
Completion
Jun 1, 2018
Last update
Aug 20, 2018

Study contacts

Zdeněk čada, M.D., Ph.D.
study chair · Charles university Prague

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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