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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06112509
Acronym
EVERS
Enrollment
20
Registered
2023-11-01
Start date
2024-02-20
Completion date
2024-11-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acoustic Neuroma, Neurinoma, Acoustic, Vestibular Schwannoma

Keywords

vestibular, schwannoma, radiosurgery, gamma-knife, neurinoma, acoustic

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.

Interventions

OTHERVestibular exam

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

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prognostic cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.1 month before gamma-knife radiosurgeryVideonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)
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 treatmentVideonystagmography: Results of caloric tests = Intervestibular deficit (in percentage)

Secondary

MeasureTime frameDescription
Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.1 month before gamma-knife radiosurgeryDizziness Handicap Inventoryquestionnaire (DHI questionnaire)
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 treatmentDizziness Handicap Inventoryquestionnaire (DHI questionnaire)

Countries

France

Contacts

Primary ContactMylene ABISSE, MD
mabisse@chu-besancon.fr+33381218988
Backup ContactPOZET Astrid
apozet@chu-besancon.fr+33381218988

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026