Vestibular SchwannomaEQUI-GAMMANCT04859335
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
A study testing gammaknife radiosurgery in people with Vestibular Schwannoma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vestibular Schwannoma
- What is being tested?
- gammaknife radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vestibular schwannoma's Patients for whom an indication of gammaknife radiosurgery was determined in a dedicated multidisciplinary consultation meeting, having not received previous treatment for this schwannoma.
- Patient affiliated to Social Security
- No opposition to participation
Who cannot join
- History of prior treatment for the presented vestibular schwannoma (surgery, fractional radiotherapy)
- History of otological or otoneurological pathology associated with schwannoma
- Patient with type 2 neurofibromatosis
- Patient under legal protection
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.
There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.
Read more
Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable.
These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.
Read the detailed description
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.
There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.
Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery.Their results are heterogeneous, on one hand, indicating little worsening of symptoms, or even improvement in some studies. On the other hand, a 2017 study reported symptomatic worsening of caloric response deficits in 17.6% of cases. Vestibular function at high frequencies or for otolithic organs (utricle and saccule) has hardly ever been explored.
The largest cohort, reported in "gammaknife radiosurgery for vestibular schwannomas a quality of life evaluation" concerns 353 patients and shows that the overall quality of life of the patients treated is on average comparable to that of the general population but that the vertigo is more frequent in this population, with a more marked impact on the overall quality of life.
These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.
Thus, the present study aims to assess the quality of balance of patients treated with Gammaknife radiosurgery for vestibular schwannoma at 1 year and 3 years after treatment.
- Conditions
- Vestibular Schwannoma
- Being tested
- gammaknife radiosurgery
- Keywords
- Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance
- Medical subject headings
- Neuroma, Acoustic, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaknife radiosurgeryRadiation
Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Schwannomas patients needing gammaknife radiosurgery | Other | Patients will undergo balance and hearing questionnaires before and after gammaknife radiosurgery.
This is a before/after analysis needing only one arm: the "before" data will serve as control to the "after" data Receives: Radiation: gammaknife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Measured: before gamma knife radiosurgery (Baseline)
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Measured: One year after gamma knife radiosurgery
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Measured: Three years after gamma knife radiosurgery
Secondary outcomes (3)
Evolution of hearing
Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)
Measured: before gamma knife radiosurgery (Baseline)
Evolution of hearing
Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)
Measured: One year after gamma knife radiosurgery
Evolution of hearing
Evaluate the evolution of hearing using data obtained during tonal audiometry (frequency by frequency between 250 Hz and 8 kHz, average hearing loss calculated on the frequencies 0.5, 1, 2, and 4 kHz)
Measured: Three years after gamma knife radiosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start21 May 2021
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (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 University Hospital, ToulouseThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu MARX, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859335
- Sponsor's protocol ID
- RC31/21/0034
- Acronym
- EQUI-GAMMA
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2021
- Last updated
- 11 Aug 2026
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA
- ClinicalTrials.gov ID
- NCT04859335
- Acronym / sponsor ID
- EQUI-GAMMA / RC31/21/0034
- Conditions
- Vestibular Schwannoma
- Keywords
- Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Apr 2021 (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.
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.
There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.
Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery, and their results are variable.
These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.
Detailed description
Vestibular schwannomas are benign lesions of the ponto-cerebellar angle that are potentially dangerous because of their growth in a cramped space and the compressive phenomena they can cause. Stereotactic Gammaknife radiosurgery is a treatment option that can be offered for evolutive schwannomas smaller than 2.5-3 cm in size. It allows tumor stabilisation in 85% of cases with less than 1% facial nerve damage risk.
There are controversial results regarding hearing preservation : percentages vary between 25 and 80% in the literature, depending on the criteria used and the post-treatment delay.
Few studies have investigated changes in vestibular function and the impact on balance of radiosurgery.Their results are heterogeneous, on one hand, indicating little worsening of symptoms, or even improvement in some studies. On the other hand, a 2017 study reported symptomatic worsening of caloric response deficits in 17.6% of cases. Vestibular function at high frequencies or for otolithic organs (utricle and saccule) has hardly ever been explored.
The largest cohort, reported in "gammaknife radiosurgery for vestibular schwannomas a quality of life evaluation" concerns 353 patients and shows that the overall quality of life of the patients treated is on average comparable to that of the general population but that the vertigo is more frequent in this population, with a more marked impact on the overall quality of life.
These controversial results lead us to comprehensively assess the vestibular function and balance of these patients using a balance-specific quality of life questionnaire, in addition to objective overall vestibular assessments of vestibular function.
Thus, the present study aims to assess the quality of balance of patients treated with Gammaknife radiosurgery for vestibular schwannoma at 1 year and 3 years after treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schwannomas patients needing gammaknife radiosurgery | Other | Radiation: gammaknife radiosurgeryPatients will undergo balance and hearing questionnaires before and after gammaknife radiosurgery. This is a before/after analysis needing only one arm: the "before" data will serve as control to the "after" data |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Vestibular schwannoma's Patients for whom an indication of gammaknife radiosurgery was determined in a dedicated multidisciplinary consultation meeting, having not received previous treatment for this schwannoma.
- Patient affiliated to Social Security
- No opposition to participation
Key exclusion criteria (5 listed)
- History of prior treatment for the presented vestibular schwannoma (surgery, fractional radiotherapy)
- History of otological or otoneurological pathology associated with schwannoma
- Patient with type 2 neurofibromatosis
- Patient under legal protection
- Pregnant or breastfeeding women
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 |
|---|---|---|
| gammaknife radiosurgeryPatients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention. | Radiation | Schwannomas patients needing gammaknife radiosurgery |
Primary outcome
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Time frame: before gamma knife radiosurgery (Baseline)
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Time frame: One year after gamma knife radiosurgery
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Time frame: Three years after gamma knife radiosurgery
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
3 secondary outcomes
Evolution of hearing
Time frame: before gamma knife radiosurgery (Baseline)
Evolution of hearing
Time frame: One year after gamma knife radiosurgery
Evolution of hearing
Time frame: Three years after gamma knife radiosurgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
Mathieu MARX, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaknife radiosurgery in people with Vestibular Schwannoma, run by University Hospital, Toulouse 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu MARX, MD Phd ((+33)5 61 77 77 04, marx.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI) (time frame: before gamma knife radiosurgery (Baseline)). The study lists 3 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 11 Aug 2026.