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Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery

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ClinicalTrials.gov Identifier: NCT03638310
Recruitment Status : Completed
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Balatkova Zuzana, 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.

Condition or disease Intervention/treatment Phase
Vestibular Schwannoma Vestibular Function Disorder Procedure: intratympanic application of gentamicin Procedure: microsurgical removal of vestibular schwannoma Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018


Arm Intervention/treatment
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
under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity

Procedure: microsurgical removal of vestibular schwannoma
surgery under general anesthesia

Active Comparator: control group
patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma.
Procedure: microsurgical removal of vestibular schwannoma
surgery under general anesthesia




Primary Outcome Measures :
  1. change of optokinetic nystagmus measurement [ 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 ]
    During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638310


Locations
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Czechia
Charles University
Prague, Czechia, 150 06
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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Study Chair: Zdeněk čada, M.D., Ph.D. Charles university Prague

Publications:
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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
ClinicalTrials.gov Identifier: NCT03638310     History of Changes
Other Study ID Numbers: 13943 FN Motol
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurilemmoma
Neuroma, Acoustic
Vestibular Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Labyrinth Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action