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Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma

Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04859335
Acronym
EQUI-GAMMA
Enrollment
50
Registered
2021-04-26
Start date
2021-05-21
Completion date
2028-12-01
Last updated
2026-08-11

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

Conditions

Vestibular Schwannoma

Keywords

Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance

Brief 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. 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.

Interventions

RADIATIONgammaknife radiosurgery

Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)before gamma knife radiosurgery (Baseline)Questionnaire including 25 items with a "yes/no/maybe" answer possibility

Secondary

MeasureTime frameDescription
Evolution of hearingbefore gamma knife radiosurgery (Baseline)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)

Countries

France

Contacts

CONTACTMathieu MARX, MD Phd
marx.m@chu-toulouse.fr(+33)5 61 77 77 04
PRINCIPAL_INVESTIGATORMathieu MARX, MD PhD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026