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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion 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".

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06112509
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Hospitalier Universitaire de Besancon
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	DAMON Veronique, MD
Principal Investigator Affiliation	CHU de Besançon
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vestibular Schwannoma, Neurinoma, Acoustic, Acoustic Neuroma

Additional Details

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.

Arms & Interventions

Arms

Other: Radiosurgery

Interventions

Other: - Vestibular exam

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Mylene ABISSE, MD

[email protected]

+33381218988

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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