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NCT Number: NCT06112509

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Vestibular exam

Other

Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.

    Time frame: 1 month before gamma-knife radiosurgery

    Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)

  2. 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

    Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)

Study contacts

Contact information is provided by the study sponsor or research team.

Mylene ABISSE, MD

CONTACT

[email protected]

+33381218988

POZET Astrid

CONTACT

[email protected]

+33381218988

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: EVERS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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