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Recruiting Not applicable

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

NCT04859335 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-05-21
Last updated
2026-08-11

Condition(s) studied

Vestibular Schwannoma

Investigational drug(s) / intervention(s)

gammaknife radiosurgery

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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) — before gamma knife radiosurgery (Baseline)
    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) — One year after gamma knife radiosurgery
    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) — Three years after gamma knife radiosurgery
    Questionnaire including 25 items with a "yes/no/maybe" answer possibility

Trial sites (1)

FacilityCityRegionStatus
CHU Toulouse Toulouse France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04859335 on ClinicalTrials.gov ↗ ← All trials in France