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Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study | Clinical Trials | Clareo Health

COMPLETEDNA

Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

NCT01938677•Karolinska Institutet

View on ClinicalTrials.gov

Summary

The effect of Gamma knife radiosurgery (GKRS) on hearing loss, in patients with vestibular schwannoma (VS) and preserved hearing is still unclear. Retrospective data indicate that the hearing is preserved in most patient years after the gamma knife treatment. Recent prospective data suggests that radiosurgery could be a hearing preserving treatment for these patients. The main objective of this study is to evaluate if GKRS can inhibit progression of hearing loss in patients with VS. Patients with preserved hearing will be offered to participate in the study and randomized ether to GKRS or initial conservative treatment for their vestibular schwannoma. They will then be followed with scheduled magnetic resonance image(MRI) and audiometry and evaluated after one, three and five years after treatment.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients newly (\<6 months) diagnosed with Vestibular schwannoma less than 20 mm in diameter.
•2. Vestibular schwannoma with or without evidence of growth.
•3. Patients between 18 and 80 years of age.
•4. Karnofsky performance score \>70
•5. Patients with vestibular schwannoma and preserved hearing according to Gardner Robertson class 1-2, and speech discrimination (SD) scores between 50-100% will participate in the hearing preservation part of the study.
•\-

Exclusion Criteria

•1\. Patients with Neurofibromatosis type 2 will be excluded to achieve a homogenous study population.
•2\. Patients who had other treatments prior to the GKRS (usually microsurgery (MS), GKRS or external beam radiation) for their tumour will also be excluded for the same reason.
•3\. Patients who are not citizens in the country where they will be followed will be excluded, to reassure the same follow up within the study population.
•4\. Hearing loss due injury or to active ear disease, such as Meniere´s disease, otosclerosis or chronic otitis media.
•5\. Patients with poor comprehension of the the language in the country where they are followed, such that adequate performance on speech tests, are unlikely.
•6\. Claustrophobia, making MR follow up impossible without sedation. 7. Alcohol- or narcotic abuses that effect compliance to the follow up. 8. Uncontrolled neoplastic disease.

Locations (1)

Department of Neurosurgery, Karolinska univeristy hospital

Stockholm, Sweden

Key Dates

Start Date

April 1, 2013

Primary Completion Date

December 1, 2022

Completion Date

December 1, 2022

Last Updated

April 18, 2024

Enrollment

ACTUAL participants

Conditions

Vestibular Schwannoma

Interventions

Initial Gamma knife radiosurgery

RADIATION

Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

NCT05641441

Vestibular SchwannomaOtotoxicity

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RECRUITINGNA

USPIO Enhanced MR Imaging in CNS Tumours (UMIC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Gamma Knife Radiosurgery vs Initial Conservative Treatment for Vestibular Schwannoma Patients With Preserved Hearing, a Prospective Randomized Study

Inclusion Criteria

Exclusion Criteria

Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

USPIO Enhanced MR Imaging in CNS Tumours (UMIC)

Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Vestibular Schwannoma

Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy

Nimodipine in Vestibular Schwanommas

Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF