An interventional study of gammaknife radiosurgery in Vestibular Schwannoma, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Health services research
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.
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.
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
This study's planned enrollment of 50 is above the median of 27 across 65 interventional studies indexed under Neuroma, Acoustic.
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Exclusion Criteria:
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
Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
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
Time frame: 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
Time frame: 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
Time frame: Three years 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)
Time frame: 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)
Time frame: 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)
Time frame: Three years after gamma knife radiosurgery
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