Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma

Study Overview
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Brief Summary
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Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk. There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay. Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable. These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.

Detailed Description
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Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk. There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay. Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery.Their results are heterogeneous, on one hand, indicating little worsening of symptoms, or even improvement in some studies. On the other hand, a 2017 study reported symptomatic worsening of caloric response deficits in 17.6% of cases. Vestibular function at high frequencies or for otolithic organs (utricle and saccule) has hardly ever been explored. The largest cohort, reported in gammaknife radiosurgery for vestibular schwannomas a quality of life evaluation concerns 353 patients and shows that the overall quality of life of the patients treated is on average comparable to that of the general population but that the vertigo is more frequent in this population, with a more marked impact on the overall quality of life. These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function. Thus, the present study aims to assess the quality of balance of patients treated with Gammaknife radiosurgery for vestibular schwannoma at 1 year and 3 years after treatment.

Official Title
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Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA

Conditions
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Vestibular Schwannoma

Intervention / Treatment
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* Radiation: gammaknife radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vestibular schwannoma's Patients for whom an indication of gammaknife radiosurgery was determined in a dedicated multidisciplinary consultation meeting, having not received previous treatment for this schwannoma. Patient affiliated to Social Security No opposition to participation Exclusion Criteria: History of prior treatment for the presented vestibular schwannoma (surgery, fractional radiotherapy) History of otological or otoneurological pathology associated with schwannoma Patient with type 2 neurofibromatosis Patient under legal protection Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Schwannomas patients needing gammaknife radiosurgery<br>Patients will undergo balance and hearing questionnaires before and after gammaknife radiosurgery. This is a before/after analysis needing only one arm: the before data will serve as control to the after data | Radiation: gammaknife radiosurgery<br>* Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) | Questionnaire including 25 items with a yes/no/maybe answer possibility | before gamma knife radiosurgery (Baseline) | 
| quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) | Questionnaire including 25 items with a yes/no/maybe answer possibility | One year after gamma knife radiosurgery | 
| quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) | Questionnaire including 25 items with a yes/no/maybe answer possibility | Three years after gamma knife radiosurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of hearing | Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz) | before gamma knife radiosurgery (Baseline) | 
| Evolution of hearing | Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz) | One year after gamma knife radiosurgery | 
| Evolution of hearing | Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz) | Three years after gamma knife radiosurgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance