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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