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

Vestibular Schwannoma Clinical Trial

— EQUI-GAMMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04859335
• Other study ID #: RC31/21/0034
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: December 1, 2028

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Mathieu MARX, MD Phd
• Phone: (+33)5 61 77 77 04
• Email: marx.m[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurilemmoma
• Neuroma, Acoustic
• Vestibular Schwannoma

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	before gamma knife radiosurgery (Baseline)
Primary	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	One year after gamma knife radiosurgery
Primary	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	Three years after gamma knife radiosurgery
Secondary	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)	before gamma knife radiosurgery (Baseline)
Secondary	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)	One year after gamma knife radiosurgery
Secondary	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)	Three years after gamma knife radiosurgery