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临床试验/NCT04859335
NCT04859335招募中不适用

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

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Schwannomas patients needing gammaknife radiosurgery

Other

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

干预措施: gammaknife radiosurgery (Radiation)

结局指标

主要结局

quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)

时间窗: Three years 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)

时间窗: 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)

时间窗: One year after gamma knife radiosurgery

Questionnaire including 25 items with a "yes/no/maybe" answer possibility

次要结局

  • Evolution of hearing(Three years after gamma knife radiosurgery)
  • Evolution of hearing(before gamma knife radiosurgery (Baseline))
  • Evolution of hearing(One year after gamma knife radiosurgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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