Acute Peripheral Vestibulopathy Following Surgical ProcedureNCT05578560
The Use of Virtual Reality in Rehabilitation in Patients After Vestibular Schwannoma Surgery.
A study testing Prehabituation, 3D optokinetic stimulation in virtual reality space and Vestibular training in people with Acute Peripheral Vestibulopathy Following Surgical Procedure, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Resection of the vestibular schwannoma leads to acute peripheral or combined vestibular loss caused by a surgical lesion to the branches of the vestibular nerve and, less frequently also the lesion of the cerebellum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Peripheral Vestibulopathy Following Surgical Procedure
- What is being tested?
- Prehabituation, 3D optokinetic stimulation in virtual reality space and Vestibular training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2020to 30 Jun 2026
- 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
- Vestibular Schwannoma appropriate to surgical resection
Who cannot join
- Eye disorder
- Oculomotor disorder in patient history
- Nerve palsy other than n. VIII, n. VII.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
Prague, Prague, 15006
About this study
Official title: Is 3D Optokinetic Stimulation in Virtual Reality Space an Efficient Tool for Improvement of Central Compensation in Patients After Vestibular Schwannoma Surgery?
Resection of the vestibular schwannoma leads to acute peripheral or combined vestibular loss caused by a surgical lesion to the branches of the vestibular nerve and, less frequently also the lesion of the cerebellum. The lesion presents in patients with postural instability, vertigo, oscillopsia, and vegetative symptoms that may accompany it. The organism reacts to this state with the process of central compensation with the significant role of the cerebellum. The goal of the rehabilitation is to support this process and thus to make recovery faster and more efficient since not all patients are capable of complete restoration of the vestibular function. Up to date, rehabilitation includes, apart from the specific vestibular exercise, also the possibility of modern techniques using virtual reality space and prehabituation. Thanks to prehabituation, i.e., chemical labyrinthectomy with intratympanically installed gentamicin, the timing of the origin of the acute vestibular loss and the surgical procedure is separated. Therefore, there is a chance of achieving vestibular compensation before vestibular schwannoma removal. In the last decade, due to the advances in technology in the field of computer games and the applications for smartphones, the tools for virtual reality have become less expensive and more available in common praxis. Virtual reality is a technique for generating an environment that can strengthen three-dimensional optokinetic stimulation, subsequently the process of central compensation. Overall, it may shorten the time of recovery after the surgery and improve patients' quality of life.
Read the detailed description
This study was approved by institutional ethics committee of the University Hospital Motol and all patients provide inform consent prior to study commencement.
In this prospective randomized single-center study, we will enroll patients who undergo vestibular schwannoma resection in our department. All patients must be found to be indicated for the surgery. The size of the tumor will be classified according to the Koos classification. The patients with hearing loss will undergo prehabituation (group A). The rest of the patients will be randomly divided into either a virtual reality group (group B), or the control group (group C). Two days before the surgery (time 1) all of the patients will undergo a clinical oto-neurological examination as well as examination by objective methods - video-nystagmography (VNG), air calorics, video Head Impulse Test (vHIT), and cervical Vestibular Evoked Myogenic Potentials (cVEMP). They will also fill out a set of questionnaires - the Penn Acoustic Neuroma Quality-Of-Life scale (PANQOL), Dizziness Handicap Inventory (DHI), Generalized Anxiety Disorder 7 - item scale (GAD-7), and Self-rating Depression Scale (SDS). All of them were translated into the Czech language. In addition to it, we used the in-house questionnaire focused on vertigo symptoms.
On the second day after the surgery, all groups of patients begin to practice the vestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session will last around 30 minutes and will happen daily for the whole time of the hospitalization, thus seven days. Additionally, during that time, group B will obtain seven sessions of 30-minute-long optokinetic stimulation via virtual reality goggles. Subjective and objective assessments will be repeated at the hospital discharge which is on the 7-10th postoperative day (time 2) and 3 months after surgery (time 3).
- Being tested
- Prehabituation, 3D optokinetic stimulation in virtual reality space, Vestibular training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabituationProcedure or surgery
chemical labyrinthectomy with intratympanically installed gentamicin
3D optokinetic stimulation in virtual reality spaceProcedure or surgery
3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp.
Vestibular trainingProcedure or surgery
vestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session lasts around 30 minutes and happened daily for the 7 postoperative days.
| Study group | Role | What they receive |
|---|---|---|
| Prehabituation group | Experimental | Patients with vestibular Schwannoma are indicated for the surgery. The patients in this group undergo chemical labyrinthectomy via intratympanically installed gentamicin before the vestibular Schwannoma resection. After the operation, vestibular training under supervision will be performed. Receives: Procedure: Prehabituation; Procedure: Vestibular training |
| Virtual reality group | Experimental | Patients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision and in addition to this, they will be exposed to 3D optokinetic stimulation in virtual reality space. Receives: Procedure: 3D optokinetic stimulation in virtual reality space; Procedure: Vestibular training |
| Vestibular training group | Experimental | Patients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision. Receives: Procedure: Vestibular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
video Head Impulse Test
Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.
Measured: 10 days after the surgery
video Head Impulse Test
Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.
Measured: 3 months after the surgery
Vestibular evoked myogenic potentials
Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.
Measured: 10 days after the surgery
Vestibular evoked myogenic potentials
Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.
Measured: 3 months after the surgery
Videonystagmography
Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.
Measured: 10 days after the surgery
Videonystagmography
Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.
Measured: 3 months after the surgery
Dizzines Handicap Inventory
Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.
Measured: 10 days after the surgery
Dizzines Handicap Inventory
Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.
Measured: 3 months after the surgery
Generalized Anxiety Disorder - 7item scale
Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.
Measured: 10 days after the surgery
Generalized Anxiety Disorder - 7item scale
Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.
Measured: 3 months after the surgery
Penn Acoustic Neuroma Quality-Of-Life scale
Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.
Measured: 10 days after the surgery
Penn Acoustic Neuroma Quality-Of-Life scale
Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.
Measured: 3 months after the surgery
Self-rating Depression Scale
Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.
Measured: 10 days after the surgery
Self-rating Depression Scale
Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.
Measured: 3 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2020
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
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 Acute Peripheral Vestibulopathy Following Surgical ProcedureStudies 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marketa Bonaventurova, Charles University, Czech Republic
- Investigators
- Markéta Bonaventurová, Principal investigator, Department of ENT and Head and Neck Surgery, Charles University in Prague and Motol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578560
- Sponsor's protocol ID
- CharlesU
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 31796939Cada 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is 3D Optokinetic Stimulation in Virtual Reality Space an Efficient Tool for Improvement of Central Compensation in Patients After Vestibular Schwannoma Surgery?
- ClinicalTrials.gov ID
- NCT05578560
- Acronym / sponsor ID
- CharlesU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Oct 2022 (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.
Resection of the vestibular schwannoma leads to acute peripheral or combined vestibular loss caused by a surgical lesion to the branches of the vestibular nerve and, less frequently also the lesion of the cerebellum. The lesion presents in patients with postural instability, vertigo, oscillopsia, and vegetative symptoms that may accompany it. The organism reacts to this state with the process of central compensation with the significant role of the cerebellum. The goal of the rehabilitation is to support this process and thus to make recovery faster and more efficient since not all patients are capable of complete restoration of the vestibular function. Up to date, rehabilitation includes, apart from the specific vestibular exercise, also the possibility of modern techniques using virtual reality space and prehabituation. Thanks to prehabituation, i.e., chemical labyrinthectomy with intratympanically installed gentamicin, the timing of the origin of the acute vestibular loss and the surgical procedure is separated. Therefore, there is a chance of achieving vestibular compensation before vestibular schwannoma removal. In the last decade, due to the advances in technology in the field of computer games and the applications for smartphones, the tools for virtual reality have become less expensive and more available in common praxis. Virtual reality is a technique for generating an environment that can strengthen three-dimensional optokinetic stimulation, subsequently the process of central compensation. Overall, it may shorten the time of recovery after the surgery and improve patients' quality of life.
Detailed description
This study was approved by institutional ethics committee of the University Hospital Motol and all patients provide inform consent prior to study commencement.
In this prospective randomized single-center study, we will enroll patients who undergo vestibular schwannoma resection in our department. All patients must be found to be indicated for the surgery. The size of the tumor will be classified according to the Koos classification. The patients with hearing loss will undergo prehabituation (group A). The rest of the patients will be randomly divided into either a virtual reality group (group B), or the control group (group C). Two days before the surgery (time 1) all of the patients will undergo a clinical oto-neurological examination as well as examination by objective methods - video-nystagmography (VNG), air calorics, video Head Impulse Test (vHIT), and cervical Vestibular Evoked Myogenic Potentials (cVEMP). They will also fill out a set of questionnaires - the Penn Acoustic Neuroma Quality-Of-Life scale (PANQOL), Dizziness Handicap Inventory (DHI), Generalized Anxiety Disorder 7 - item scale (GAD-7), and Self-rating Depression Scale (SDS). All of them were translated into the Czech language. In addition to it, we used the in-house questionnaire focused on vertigo symptoms.
On the second day after the surgery, all groups of patients begin to practice the vestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session will last around 30 minutes and will happen daily for the whole time of the hospitalization, thus seven days. Additionally, during that time, group B will obtain seven sessions of 30-minute-long optokinetic stimulation via virtual reality goggles. Subjective and objective assessments will be repeated at the hospital discharge which is on the 7-10th postoperative day (time 2) and 3 months after surgery (time 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prehabituation group | Experimental | Procedure: Prehabituation, Procedure: Vestibular trainingPatients with vestibular Schwannoma are indicated for the surgery. The patients in this group undergo chemical labyrinthectomy via intratympanically installed gentamicin before the vestibular Schwannoma resection. After the operation, vestibular training under supervision will be performed. |
| Virtual reality group | Experimental | Procedure: 3D optokinetic stimulation in virtual reality space, Procedure: Vestibular trainingPatients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision and in addition to this, they will be exposed to 3D optokinetic stimulation in virtual reality space. |
| Vestibular training group | Experimental | Procedure: Vestibular trainingPatients with vestibular Schwannoma are indicated for the surgery. After the surgery, they will perform vestibular training under supervision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vestibular Schwannoma appropriate to surgical resection
Key exclusion criteria (3 listed)
- Eye disorder
- Oculomotor disorder in patient history
- Nerve palsy other than n. VIII, n. VII.
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 |
|---|---|---|
| Prehabituationchemical labyrinthectomy with intratympanically installed gentamicin | Procedure or surgery | Prehabituation group |
| 3D optokinetic stimulation in virtual reality space3D optokinetic stimulation via virtual reality goggles with the software designed by Pro-Zeta comp. | Procedure or surgery | Virtual reality group |
| Vestibular trainingvestibular training program adopted for patients with acute vestibular loss under the supervision of a physical therapist. The program includes gaze stability exercises, smooth pursuit, and saccadic eye movements, and postural exercises to improve balance control and gait stability. Each session lasts around 30 minutes and happened daily for the 7 postoperative days. | Procedure or surgery | Prehabituation group, Vestibular training group, Virtual reality group |
Primary outcome
video Head Impulse Test
Time frame: 10 days after the surgery
Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.
video Head Impulse Test
Time frame: 3 months after the surgery
Objective method. The video head impulse test is an ear-specific test that detects disorders of the vestibulo-ocular reflex and identifies which ear is affected in cases of peripheral vestibular loss. It can test all three semicircular canal in each ear independently. Patients with a vestibular loss exhibit a corrective saccadic eye movement (a "catch-up" saccade) either during or after the head impulse and the gain of the head in comparison to the eye will not be equivalent.
Vestibular evoked myogenic potentials
Time frame: 10 days after the surgery
Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.
Vestibular evoked myogenic potentials
Time frame: 3 months after the surgery
Objective method. Vestibular evoked myogenic potentials are short-latency, vestibular-dependent reflexes that are recorded from the sternocleidomastoid muscles in the anterior neck (cervical VEMPs - cVEMPs) and the inferior oblique extraocular muscles (ocular VEMPs - oVEMPs). They are evoked by short bursts of sound delivered through headphones (air conducted) or vibration applied to the skull (bone conducted). As these stimuli have been shown to preferentially activate otolith organs rather than semicircular canals, VEMPs are used clinically as measures of otolith function. They are used to reveal loss of otolith function, i.e. in conditions where damage to the inner ear, vestibular nerve, or central vestibular pathways occurs.
Videonystagmography
Time frame: 10 days after the surgery
Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.
Videonystagmography
Time frame: 3 months after the surgery
Objective method. It is a technology for testing inner ear and central motor functions, a process known as vestibular assessment. It involves the use of infrared goggles to trace eye movements during visual stimulation and positional changes.
Dizzines Handicap Inventory
Time frame: 10 days after the surgery
Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.
Dizzines Handicap Inventory
Time frame: 3 months after the surgery
Subjective method. It evaluates the self-perceived handicapping effects of dizziness in everyday life imposed by vestibular system disease. It contains 25-items, which are subgrouped into three content domains representing functional, emotional and physical aspects of dizziness and unsteadiness. Scoring of the DHI is as follows, a "yes" answer is awarded 4 points, "sometimes," 2 points and "no," 0 points. Possible scores range from 0, suggesting no handicap, to 100, indicating significant self-perceived handicap.
Generalized Anxiety Disorder - 7item scale
Time frame: 10 days after the surgery
Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.
Generalized Anxiety Disorder - 7item scale
Time frame: 3 months after the surgery
Subjective method. This questionnaire is a valid and efficient tool for screening for generalized anxiety disorder and assessing its severity in clinical practice and research. Because of the 7 items is scored from 0 to 3, the GAD- 7 scale score ranges from 0 to 21. Increasing scores on the scale are strongly associated with the functional impairment.
Penn Acoustic Neuroma Quality-Of-Life scale
Time frame: 10 days after the surgery
Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.
Penn Acoustic Neuroma Quality-Of-Life scale
Time frame: 3 months after the surgery
Subjective method. This questionnaire is a valid and reliable disease-specific quality of life instrument for acoustic neuroma. Since the vestibular schwannomas are benign tumors such quality of life is a paramount of importance when considering treatment options. It consists of 26 questions covering all relevant domains such as hearing, balance, anxiety, energy, pain and general. Answer to each question is scored in range from 1 to 5, meaning the total score ranges from 26 to 130, the higher score indicates the worse quality of life.
Self-rating Depression Scale
Time frame: 10 days after the surgery
Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.
Self-rating Depression Scale
Time frame: 3 months after the surgery
Subjective method. It assess depression simply and specifically as a psychiatric disorder. It is constructed so that the less depressed patient and his complaints will have low score on the scale, and the more depressed patient and his complaints will have a higher score. In scoring SDS, which contains 20 items, a value of 1 to 4 is assigned to a response depending upon whether the item was worded positively or negatively. An index for the SDS was derived by dividing the sum of the values obtained on the 20 items by the maximum possible score of 80 and expressed as a decimal.
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 22 Oct 2026.
- Background: 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.
- 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.
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.
Markéta Bonaventurová principal investigator
Department of ENT and Head and Neck Surgery, Charles University in Prague and Motol University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabituation, 3D optokinetic stimulation in virtual reality space and Vestibular training in people with Acute Peripheral Vestibulopathy Following Surgical Procedure, 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 1 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 22 Oct 2026. 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?
video Head Impulse Test (time frame: 10 days after the surgery). The study lists 14 primary outcomes in all. 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 NCT05578560, 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 22 Oct 2026.