跳至主要内容
临床试验/NCT06112509
NCT06112509招募中不适用

Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife

Centre Hospitalier Universitaire de Besancon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月20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
20
试验地点
1
主要终点
Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

研究概览

简要总结

The purpose of this study is to evaluate the vestibular effects of gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

详细描述

Vestibular schwannoma is a benign tumor located on the vestibulocochlear nerve. It represents 6 to 8% of intracranial tumors, 80% of ponto-cerebral angle tumors and its frequency is 13 cases per million inhabitants per year.

The main symptoms related to the development of vestibular schwannoma are unilateral deafness of perception, unilateral tinnitus, unilateral vestibular deficit vertigo, facial paralysis.

Management is divided into 3 options: monitoring, surgery and gamma-knife radiosurgery.

This study will focus on gamma-knife radiosurgery. The objective of this treatment is to stabilize the evolution of schwannoma.

This study aims to describe the vestibular effects of radiosurgery.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women aged 18 to 90 included
  • •Subject who benefited from gamma-knife radiosurgery as part of the treatment of vestibular schwannoma
  • •Non-opposition of the subject to participate in the study
  • •Affiliation to a French social security scheme or beneficiary of such a scheme

排除标准

  • •Subject with another vestibular pathology
  • •Subject who did not benefit from a vestibular assessment before treatment with gamma-knife radiosurgery
  • •Legal incapacity or limited legal capacity
  • •Subject unlikely to cooperate in the study and/or weak cooperation anticipated by the investigator
  • •Subject without health insurance
  • •Subject being in the period of exclusion from another study or provided for by the "national volunteer file".

研究组 & 干预措施

Radiosurgery

Other

干预措施: Vestibular exam (Other)

结局指标

主要结局

Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

时间窗: After gamma-knife radiosurgery at 6 month or 12 month or 18 month or 2 years or 3 years depending on the history of the treatment

Videonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)

Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.

时间窗: 1 month before gamma-knife radiosurgery

Videonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)

次要结局

  • Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.(After gamma-knife radiosurgery at 6 month or 12 month or 18 month or 2 years or 3 years depending on the history of the treatment)
  • Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.(1 month before gamma-knife radiosurgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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