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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • gammaknife radiosurgery

    Radiation

    Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Schwannomas patients needing gammaknife radiosurgeryOther 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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
3

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

Secondary outcomes

1

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)
2

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
3

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

Other outcomes

Sponsors and contacts

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