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

NCT ID: NCT06112509

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2024-11-01

Brief Summary

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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

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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.

Conditions

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Vestibular Schwannoma Neurinoma, Acoustic Acoustic Neuroma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prognostic cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiosurgery

Group Type OTHER

Vestibular exam

Intervention Type OTHER

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

Interventions

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Vestibular exam

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

Intervention Type OTHER

Eligibility Criteria

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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".
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DAMON Veronique, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

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CHU de Besançon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mylene ABISSE, MD

Role: CONTACT

+33381218988

POZET Astrid

Role: CONTACT

+33381218988

Facility Contacts

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Astrid Pozet

Role: primary

+33381218988

Other Identifiers

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2023/823

Identifier Type: -

Identifier Source: org_study_id

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