Cochlear Implantation After Gamma Knife Radiosurgery With eABR and Correlation to Postoperative Hearing Results - a Pilot Study

Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss; Vestibular Schwannoma
• Intervention / Treatment: Other: eABR

Detailed Description

Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.

• Study Type: Observational
• Enrollment (Anticipated): 8

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • AKH; MUW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after radio surgery for vestibular schwannoma undergoing cochlear implantation

Description

Inclusion Criteria:

• Patients who have undergone radio surgery for vestibular schwannoma
• Patients wanting cochlear implantation for hearing rehabilitation

Exclusion Criteria:

• Patients not wanting to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eABR correlation	eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB	2 years

Collaborators and Investigators

• Sponsor: Christoph Arnoldner

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (ACTUAL): November 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Sensation Disorders; Neuroendocrine Tumors; Hearing Disorders; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Hearing Loss; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: 1564/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No