Actively Recruiting
Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
Led by Christoph Arnoldner · Updated on 2024-11-25
8
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate cochlear implantation in patients who have undergone radiosurgery for vestibular schwannoma, a condition often leading to hearing loss. The study focuses on assessing the relationship between electrically evoked auditory brainstem response (eABR) measurements and postoperative hearing outcomes, particularly speech understanding using cochlear implants. It is an observational pilot study that helps determine if cochlear implantation is feasible and beneficial after radiosurgery, especially when hearing loss progresses on the opposite side. Participants will undergo extensive audiometric testing and eABR measurements before and during cochlear implantation surgery. The eABR results, which are not considered part of the study intervention, will be categorized into good, weak, or no response groups. Researchers will then correlate these eABR responses with postoperative speech understanding measured by the Freiburger monosyllables test. During the study, participants will be evaluated through hearing tests and eABR recordings preoperatively and intraoperatively. The primary outcome measure is the correlation between eABR results and hearing performance two years after cochlear implantation. The study will monitor participants to observe these outcomes and gather data to better understand hearing rehabilitation after vestibular schwannoma radiosurgery. The total duration of follow-up and further safety monitoring details are not specified.
CONDITIONS
Brief Title
Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone radio surgery for vestibular schwannoma
- Patients wanting cochlear implantation for hearing rehabilitation
- Adults aged 18 years or older
You will not qualify if you...
- Patients not wanting to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 month before implantation
Participants undergo extensive audiometric testing and preoperative eABR assessments to evaluate cochlear implantation feasibility.
Multiple visits for testing and assessments
Duration - Surgery day plus immediate recovery period
Participants receive cochlear implantation with intraoperative eABR measurements performed during the procedure.
1 surgical visit plus recovery care
Duration - Up to 2 years
Participants are monitored to assess postoperative hearing and speech understanding with cochlear implants correlated with eABR results.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
AKH; MUW
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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