Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: gammaknife radiosurgery.
- Who it may be relevant to
- Registry conditions: Vestibular Schwannoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA
Overview
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
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.
Interventions
- Radiation gammaknife radiosurgery
Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
Primary outcome measures
- quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Time frame: before gamma knife radiosurgery (Baseline)]
- quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Time frame: One year after gamma knife radiosurgery]
- quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Time frame: Three years after gamma knife radiosurgery]
Secondary outcome measures (3)
- Evolution of hearing [Time frame: before gamma knife radiosurgery (Baseline)]
- Evolution of hearing [Time frame: One year after gamma knife radiosurgery]
- Evolution of hearing [Time frame: Three years after gamma knife radiosurgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
France · 1 center
- CHU Toulouse — Toulouse
Identifiers
NCT: NCT04859335 · RC31/21/0034