Vestibular SchwannomaNCT03638310
Role of Psychiatric Profile in Prehabituated Patients After Vestibular Schwannoma Surgery
A study testing intratympanic application of gentamicin and microsurgical removal of vestibular schwannoma in people with Vestibular Schwannoma and Vestibular Function Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Schwannoma, Vestibular Function Disorder
- What is being tested?
- intratympanic application of gentamicin and microsurgical removal of vestibular schwannoma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2016to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T3, T4 vestibular schwannoma
- recorded growth of a tumour
- hearing loss greater than 50% in PTA
Who cannot join
- T1 vestibular schwannomas
- no growth progression
- normal hearing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
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.
- Being tested
- intratympanic application of gentamicin, microsurgical removal of vestibular schwannoma
- Medical subject headings
- Neuroma, Acoustic, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intratympanic application of gentamicinProcedure or surgery
under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity
microsurgical removal of vestibular schwannomaProcedure or surgery
surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: intratympanic application of gentamicin; Procedure: microsurgical removal of vestibular schwannoma |
| control group | Active comparator | patients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma. Receives: Procedure: microsurgical removal of vestibular schwannoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of optokinetic nystagmus measurement
During electronystagmography gain of optokinetic nystagmus is measured before and after the intervention
Measured: change of the gain of optokinetic nystagmus among 3 time points is measured: before intervention, 1 week after intervention, 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jan 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balatkova Zuzana, Charles University, Czech Republic
- Investigators
- Zdeněk čada, M.D., Ph.D., Study chair, Charles university Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638310
- Sponsor's protocol ID
- 13943 FN Motol
- Status last verified
- Aug 2018
- First submitted
- 8 May 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
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 28053986Balatkova 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Visual Sensitivity, Psychiatric Profile and Quality of Life Following Vestibular Schwannoma Surgery in Patients Prehabituated by Chemical Vestibular Ablation
- ClinicalTrials.gov ID
- NCT03638310
- Acronym / sponsor ID
- 13943 FN Motol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups of patients, one group prehabituated by chemical labyrintectomy, the second control group without prehabituation before the surgery
| Arm | Type | Receives |
|---|---|---|
| ITG (intratympanic gentamicin) group | Experimental | Procedure: intratympanic application of gentamicin, Procedure: microsurgical removal of vestibular schwannomaPatients 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 | Active comparator | Procedure: microsurgical removal of vestibular schwannomapatients without prehabituation before surgery. They underwent microsurgical removal of vest. schwannoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- T3, T4 vestibular schwannoma
- recorded growth of a tumour
- hearing loss greater than 50% in PTA
Key exclusion criteria (3 listed)
- T1 vestibular schwannomas
- no growth progression
- normal hearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intratympanic application of gentamicinunder local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity | Procedure or surgery | ITG (intratympanic gentamicin) group |
| microsurgical removal of vestibular schwannomasurgery under general anesthesia | Procedure or surgery | ITG (intratympanic gentamicin) group, control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Background: PubMed 28053986Cada 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.
- Derived from this study: PubMed 31796939Balatkova 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zdeněk čada, M.D., Ph.D. study chair
Charles university Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intratympanic application of gentamicin and microsurgical removal of vestibular schwannoma in people with Vestibular Schwannoma and Vestibular Function Disorder, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.