Image-Guided Programming for Cochlear Implants
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Image-Guided Programming for Cochlear Implants?
Is image-guided cochlear implant programming safe for humans?
Research on image-guided cochlear implant programming, including minimally invasive techniques, has been conducted to assess safety, focusing on the forces and trauma during implantation. These studies aim to ensure the procedure is safe, although specific safety outcomes are not detailed in the abstracts provided.12367
How does image-guided programming for cochlear implants differ from other treatments for hearing loss?
Image-guided programming for cochlear implants is unique because it uses CT images to customize the settings of the implant based on the specific positions of the electrodes and nerves in each patient. This personalized approach aims to improve hearing outcomes by reducing issues like cross-electrode neural stimulation overlap, which is not addressed by the standard one-size-fits-all programming method.14589
What is the purpose of this trial?
This trial tests a new method that uses detailed images to fine-tune cochlear implants. It targets patients who haven't improved much with standard programming. By turning off poorly placed electrodes, it aims to provide clearer hearing. This technique is developed to locate the position of cochlear implant electrodes for patient-customized settings.
Research Team
Robert F. Labadie, MD, PhD
Principal Investigator
Vanderbilt University Medical Center
Rene H. Gifford, PhD
Principal Investigator
Vanderbilt University Medical Center
Jack H. Noble, PhD
Principal Investigator
Vanderbilt University
Eligibility Criteria
This trial is for adults aged 18 to 90 with sensorineural hearing loss who have received a cochlear implant and seen limited improvement. Candidates must speak English due to the test battery used. Pregnant individuals or those outside the age range are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Post-operative CT Scanning
Participants undergo post-operative CT scanning to determine the relationship between cochlear implant electrodes and the neural interface
Image-guided Cochlear Implant Programming (IGCIP) Trial
Participants undergo a 1-month trial of IGCIP where sub-optimally placed electrodes are deactivated
Follow-up
Participants are monitored for audiological outcomes and can choose between IGCIP or SOC for long-term programming
Treatment Details
Interventions
- Cochlear Implant Surgery
- Image-Guided Cochlear Implant Programming
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator