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

NCT ID: NCT03745534

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2026-10-30

Brief Summary

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.

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.

Conditions

Vestibular Schwannoma; Hearing Loss

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

eABR

eABR

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christoph Arnoldner

OTHER

Sponsor Role: lead

Responsible Party

Christoph Arnoldner

Assoc Prof PD. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

AKH; MUW

Vienna, Vienna, Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Valerie Dahm, MD

Role: primary

valerie.dahm@meduniwien.ac.at

004314040033300

Other Identifiers

1564/2018

Identifier Type: -

Identifier Source: org_study_id