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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03745534
Enrollment
8
Registered
2018-11-19
Start date
2018-08-01
Completion date
2026-10-30
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Vestibular Schwannoma

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.

Interventions

OTHEReABR

eABR

Sponsors

Christoph Arnoldner
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
eABR correlation2 yearseABR 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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026