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Recruiting NCT06112509

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

No phase Interventional Vestibular Schwannoma Neurinoma, Acoustic Acoustic Neuroma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vestibular exam.
Who it may be relevant to
Registry conditions: Vestibular Schwannoma, Neurinoma, Acoustic, Acoustic Neuroma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Other Vestibular exam
    Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test

Primary outcome measures

  • Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma. [Time frame: 1 month before gamma-knife radiosurgery]
  • Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma. [Time frame: 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]
Secondary outcome measures (2)
  • Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma. [Time frame: 1 month before gamma-knife radiosurgery]
  • Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma. [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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".

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Besançon — Besançon

Identifiers

NCT: NCT06112509 · 2023/823

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗