About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
gammaknife radiosurgery
RadiationPatients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
Secondary outcomes
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)
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)
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.