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

NCT ID: NCT04859335

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2028-12-01

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.

Conditions

Vestibular Schwannoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Schwannomas patients needing gammaknife radiosurgery

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

Group Type: OTHER

gammaknife radiosurgery

Intervention Type: RADIATION

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

Interventions

gammaknife radiosurgery

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathieu MARX, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mathieu MARX, MD Phd

Role: CONTACT

marx.m@chu-toulouse.fr

(+33)5 61 77 77 04

Facility Contacts

Mathieu MARX

Role: primary

Other Identifiers

RC31/21/0034

Identifier Type: -

Identifier Source: org_study_id