Vestibular SchwannomaEVERSNCT06112509
Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife Radio-surgery
A study testing Vestibular exam in people with Vestibular Schwannoma and Neurinoma, Acoustic, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of this study is to evaluate the vestibular effects of gamma-knife radiosurgery, as part of the treatment of vestibular schwannoma. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Schwannoma, Neurinoma, Acoustic, Acoustic Neuroma
- What is being tested?
- Vestibular exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Astrid Pozet, +33381218988, apozet@chu-besancon.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Schwannoma, Neurinoma, Acoustic, Acoustic Neuroma
- Being tested
- Vestibular exam
- Keywords
- vestibular, schwannoma, radiosurgery, gamma-knife, neurinoma, acoustic
- Medical subject headings
- Neuroma, Acoustic, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular examOther
Interrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery | Other | Not described Receives: Other: Vestibular exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)
Measured: 1 month before gamma-knife radiosurgery
Description of vestibular symptoms after gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
Dizziness Handicap Inventoryquestionnaire (DHI questionnaire)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start20 Feb 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prognostic cohort study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAMON Veronique, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112509
- Sponsor's protocol ID
- 2023/823
- Acronym
- EVERS
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Vestibular Function After Treatment of a Vestibular Schwannoma by Gamma-knife
- ClinicalTrials.gov ID
- NCT06112509
- Acronym / sponsor ID
- EVERS / 2023/823
- Conditions
- Vestibular Schwannoma, Neurinoma, Acoustic, Acoustic Neuroma
- Keywords
- vestibular, schwannoma, radiosurgery, gamma-knife, neurinoma, acoustic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prognostic cohort study
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery | Other | Other: Vestibular exam |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular examInterrogation, videonystagmoscopy, videonystagmography, video-head-impulse-test | Other | Radiosurgery |
Primary outcome
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)
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)
2 secondary outcomes
Description of vestibular symptoms before gamma-knife radiosurgery as part of the treatment of vestibular schwannoma.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAMON Veronique, MD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular exam in people with Vestibular Schwannoma and Neurinoma, Acoustic, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mylene ABISSE, MD (+33381218988, mabisse@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.