Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04859335

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

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gammaknife radiosurgery

Radiation

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Evolution of hearing

    Time frame: before 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)

  2. Evolution of hearing

    Time frame: One year after gamma knife radiosurgery

    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)

  3. Evolution of hearing

    Time frame: Three years after gamma knife radiosurgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Mathieu MARX, MD Phd

CONTACT

[email protected]

(+33)5 61 77 77 04

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: EQUI-GAMMA

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 26, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.