Assessing balance and vestibular function after Gammaknife treatment for vestibular schwannoma
Prospective Study : Long-term Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma EQUI-GAMMA
NA · University Hospital, Toulouse · NCT04859335
This study tests how Gammaknife treatment for vestibular schwannomas affects balance and inner ear function in patients who haven't had other treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04859335 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Gammaknife radiosurgery on balance and vestibular function in patients with vestibular schwannomas. It aims to comprehensively assess changes in vestibular function and balance using both subjective quality of life questionnaires and objective vestibular assessments. The study focuses on patients with schwannomas smaller than 2.5-3 cm who have not received prior treatment. The results will help clarify the impact of this treatment on patients' balance and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with vestibular schwannomas who are eligible for Gammaknife radiosurgery and have not undergone previous treatments.
Not a fit: Patients with a history of prior treatment for vestibular schwannomas or those with associated otological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the preservation of balance and vestibular function after Gammaknife treatment, improving patient management and outcomes.
How similar studies have performed: While there have been studies on Gammaknife radiosurgery for vestibular schwannomas, comprehensive assessments of vestibular function and balance post-treatment are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- CHU Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Mathieu MARX, MD PhD — University Hospital, Toulouse
- Study coordinator: Mathieu MARX, MD Phd
- Email: marx.m@chu-toulouse.fr
- Phone: (+33)5 61 77 77 04
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vestibular Schwannoma, Gammaknife radiosurgery, Dizziness, Balance