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

Vestibular Schwannoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112509
• Other study ID #: 2023/XXXX
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Mylene ABISSE, MD
• Phone: +33381218988
• Email: mabisse[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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".

Related Conditions & MeSH terms

• Acoustic Neuroma
• Neurilemmoma
• Neuroma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

Other:
• Vestibular exam
Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.	Videonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)	1 month before gamma-knife radiosurgery
Primary	Description of vestibular function with vidéonystagmoscopy before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.	Videonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)	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	Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.	Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)	1 month before gamma-knife radiosurgery
Secondary	Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.	Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)	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