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

Официальное название

Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Срок оценки: before gamma knife radiosurgery (Baseline)]
• quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Срок оценки: One year after gamma knife radiosurgery]
• quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) [Срок оценки: Three years after gamma knife radiosurgery]

Вторичные конечные точки (3)

• Evolution of hearing [Срок оценки: before gamma knife radiosurgery (Baseline)]
• Evolution of hearing [Срок оценки: One year after gamma knife radiosurgery]
• Evolution of hearing [Срок оценки: Three years after gamma knife radiosurgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• CHU Toulouse — Toulouse

Идентификаторы

NCT: NCT04859335 · RC31/21/0034

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗