Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma (EQUI-GAMMA)
Primary Purpose
Vestibular Schwannoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gammaknife radiosurgery
Sponsored by
About this trial
This is an interventional health services research trial for Vestibular Schwannoma focused on measuring Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance
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
Sites / Locations
- CHU ToulouseRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Schwannomas patients needing gammaknife radiosurgery
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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)
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)
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)
Full Information
NCT ID
NCT04859335
First Posted
April 16, 2021
Last Updated
July 10, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04859335
Brief Title
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Schwannoma
Keywords
Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Schwannomas patients needing gammaknife radiosurgery
Arm Type
Other
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
gammaknife radiosurgery
Intervention Description
Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
Primary Outcome Measure Information:
Title
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Description
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Time Frame
before gamma knife radiosurgery (Baseline)
Title
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Description
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Time Frame
One year after gamma knife radiosurgery
Title
quality of the perceived balance, assessed by the French version of the Dizziness Handicap Inventory (DHI)
Description
Questionnaire including 25 items with a "yes/no/maybe" answer possibility
Time Frame
Three years after gamma knife radiosurgery
Secondary Outcome Measure Information:
Title
Evolution of hearing
Description
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)
Time Frame
before gamma knife radiosurgery (Baseline)
Title
Evolution of hearing
Description
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)
Time Frame
One year after gamma knife radiosurgery
Title
Evolution of hearing
Description
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)
Time Frame
Three years after gamma knife radiosurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu MARX, MD Phd
Phone
(+33)5 61 77 77 04
Email
marx.m@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu MARX, MD PhD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu MARX
12. IPD Sharing Statement
Learn more about this trial
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
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