Actively Recruiting
Prospective Study of Long-term Balance and Vestibular Function Changes in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
Led by University Hospital, Toulouse · Updated on 2024-08-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying vestibular schwannomas, which are benign tumors near the brain that can cause problems due to their growth in a small area. They are evaluating how balance and vestibular function change in patients treated with Gammaknife radiosurgery, a focused radiation treatment used for tumors smaller than 2.5 to 3 cm. This treatment stabilizes tumors in many cases and has a low risk of facial nerve damage, but there is uncertainty about how well it preserves hearing and affects balance over time. Patients with vestibular schwannomas will complete balance and hearing questionnaires before receiving Gammaknife radiosurgery and again at one year and three years after treatment. This study uses a before-and-after design, with patients serving as their own controls. The intervention consists of Gammaknife radiosurgery, and researchers will assess changes in vestibular function and quality of life related to balance. Participants will be asked to complete the French version of the Dizziness Handicap Inventory to measure their perceived balance quality before treatment, and at one and three years afterward. Hearing evolution will also be monitored at these three time points. The study involves ongoing assessments to understand how balance and hearing evolve after radiosurgery, with a total follow-up period of three years.
CONDITIONS
Brief Title
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with vestibular schwannoma recommended for Gammaknife radiosurgery by a multidisciplinary team
- No previous treatment for the vestibular schwannoma
- Affiliated with Social Security
- No opposition to participation in the study
- Age between 18 and 65 years
You will not qualify if you...
- Prior treatment for vestibular schwannoma, including surgery or fractional radiotherapy
- History of other ear or neurological conditions linked to the schwannoma
- Diagnosis of type 2 neurofibromatosis
- Under legal protection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive Gammaknife radiosurgery for vestibular schwannoma.
1 treatment visit (in-person)
Duration - 3 years
Participants complete balance and hearing questionnaires before treatment, and one year and three years after treatment to assess changes in vestibular function and quality of balance.
3 visits (in-person) including baseline before treatment, 1 year, and 3 years post-treatment
Trial Site Locations
Total: 1 location
1
CHU Toulouse
Toulouse, France
Actively Recruiting
Research Team
M
Mathieu MARX, MD Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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