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

NCT ID: NCT06112509

Condition: Vestibular Schwannoma
Neurinoma, Acoustic
Acoustic Neuroma

Conditions: Official terms:
Neurilemmoma
Neuroma
Neuroma, Acoustic

Conditions: Keywords:
vestibular
schwannoma
radiosurgery
gamma-knife
neurinoma
acoustic

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Prognostic cohort study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Vestibular exam
Description: Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test
Arm group label: Radiosurgery

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.

Criteria for 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".

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: CHU de Besançon

Address:
City: Besançon
Country: France

Status: Recruiting

Contact:
Last name: Astrid Pozet

Phone: +33381218988
Email: apozet@chu-besancon.fr

Start date: February 20, 2024

Completion date: November 1, 2024

Lead sponsor:
Agency: Centre Hospitalier Universitaire de Besancon
Agency class: Other

Source: Centre Hospitalier Universitaire de Besancon

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06112509

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