Clinical trial NCT05578560: The Use of Virtual Reality in Rehabilitation in Patients After Vestibular Schwannoma Surgery.
Official title: Is 3D Optokinetic Stimulation in Virtual Reality Space an Efficient Tool for Improvement of Central Compensation in Patients After Vestibular Schwannoma Surgery?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Peripheral Vestibulopathy Following Surgical Procedure
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* Vestibular Schwannoma appropriate to surgical resection

Exclusion Criteria:

* Eye disorder
* Oculomotor disorder in patient history
* Nerve palsy other than n. VIII, n. VII.

Primary outcomes:
measure: video Head Impulse Test
timeFrame: 10 days after the surgery
measure: video Head Impulse Test
timeFrame: 3 months after the surgery
measure: Vestibular evoked myogenic potentials
timeFrame: 10 days after the surgery
measure: Vestibular evoked myogenic potentials
timeFrame: 3 months after the surgery
measure: Videonystagmography
timeFrame: 10 days after the surgery
measure: Videonystagmography
timeFrame: 3 months after the surgery
measure: Dizzines Handicap Inventory
timeFrame: 10 days after the surgery
measure: Dizzines Handicap Inventory
timeFrame: 3 months after the surgery
measure: Generalized Anxiety Disorder - 7item scale
timeFrame: 10 days after the surgery
measure: Generalized Anxiety Disorder - 7item scale
timeFrame: 3 months after the surgery
measure: Penn Acoustic Neuroma Quality-Of-Life scale
timeFrame: 10 days after the surgery
measure: Penn Acoustic Neuroma Quality-Of-Life scale
timeFrame: 3 months after the surgery
measure: Self-rating Depression Scale
timeFrame: 10 days after the surgery
measure: Self-rating Depression Scale
timeFrame: 3 months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Otorhinolaryngology and Head and Neck Surgery, 1st Faculty of Medicine Charles University and Motol University Hospital, Postgraduate Medical School
Study officials:
affiliation: Department of ENT and Head and Neck Surgery, Charles University in Prague and Motol University Hospital
name: Markéta Bonaventurová
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.