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

Not Applicable

Not yet recruiting

• Conditions: Vestibular Schwannoma; Neurinoma, Acoustic; Acoustic Neuroma
• Interventions: Other: Vestibular exam

• Registration Number: NCT06112509
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-27
• Last Update Submitted: 2023-10-27
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Study Start: 2024-01-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiosurgery	Vestibular exam	-

Primary Outcome Measures

Name	Time	Method
Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.	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)
Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.	1 month before gamma-knife radiosurgery	Videonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)

Secondary Outcome Measures

Name	Time	Method
Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.	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)
Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.	1 month before gamma-knife radiosurgery	Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France