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

October 27, 2023 updated by: Centre Hospitalier Universitaire de Besancon

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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".

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Radiosurgery
Other: Vestibular exam
Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of vestibular function with videonystagmography before gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma.
Time Frame: 1 month before gamma-knife radiosurgery
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.
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
Time Frame: 1 month before gamma-knife radiosurgery
Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)
1 month before gamma-knife radiosurgery
Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: DAMON Veronique, MD, CHU de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/XXXX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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