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

NCT04859335 | Recruiting

• 1 other identifier: RC31/21/0034
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma

Keywords

Vestibular Schwannoma; Gammaknife radiosurgery; Dizziness; Balance

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (3)

• Evolution of hearing

  before gamma knife radiosurgery (Baseline)

• Evolution of hearing

  One year after gamma knife radiosurgery

• Evolution of hearing

  Three years after gamma knife radiosurgery

Study Arms (1)

Schwannomas patients needing gammaknife radiosurgery

OTHER

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

Radiation: gammaknife radiosurgery

Interventions

gammaknife radiosurgery RADIATION

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

Schwannomas patients needing gammaknife radiosurgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic; Dizziness

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mathieu MARX, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu MARX, MD Phd

CONTACT

(+33)5 61 77 77 04; marx.m@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: May 21, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

FR (1)