Clinical trial NCT06112509: Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery
Official title: Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Schwannoma
Neurinoma, Acoustic
Acoustic Neuroma
Keywords: vestibular
schwannoma
radiosurgery
gamma-knife
neurinoma
acoustic
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prognostic cohort study
Primary purpose: TREATMENT

Brief summary: 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.

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".

Primary outcomes:
measure: Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.
timeFrame: 1 month before gamma-knife radiosurgery
measure: Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.
timeFrame: 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 outcomes:
measure: Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
timeFrame: 1 month before gamma-knife radiosurgery
measure: Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
timeFrame: 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
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: DAMON Veronique, MD
role: PRINCIPAL_INVESTIGATOR
References: