Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery
EVERS
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedStudy Start
First participant enrolled
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedSeptember 19, 2024
September 1, 2024
9 months
October 20, 2023
September 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
1 month before gamma-knife radiosurgery
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
Study Arms (1)
Radiosurgery
OTHERInterventions
Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Besançon
Besançon, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DAMON Veronique, MD
CHU de Besançon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2023
First Posted
November 1, 2023
Study Start
February 20, 2024
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09