150 Participants Needed

Image-Guided Programming for Cochlear Implants

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that using image-guided programming for cochlear implants can improve hearing outcomes in both children and adults. This method helps customize the implant settings by using images to better match the electrodes with the nerves they stimulate, leading to better hearing results.12345

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

RF

Robert F. Labadie, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

RH

Rene H. Gifford, PhD

Principal Investigator

Vanderbilt University Medical Center

JH

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

I am between 18 and 90 years old, have sensorineural hearing loss, and received a cochlear implant.

Exclusion Criteria

I am not pregnant, as it would prevent me from having certain medical scans and surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative CT Scanning

Participants undergo post-operative CT scanning to determine the relationship between cochlear implant electrodes and the neural interface

1 week
1 visit (in-person)

Image-guided Cochlear Implant Programming (IGCIP) Trial

Participants undergo a 1-month trial of IGCIP where sub-optimally placed electrodes are deactivated

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for audiological outcomes and can choose between IGCIP or SOC for long-term programming

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Cochlear Implant Surgery
  • Image-Guided Cochlear Implant Programming
Trial Overview The study tests 'Image-guided Cochlear Implant Programming' (IGCIP), which uses post-op CT scans to map out where cochlear implant electrodes sit in relation to the neural interface, potentially improving hearing by deactivating poorly positioned electrodes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Image-guided Cochlear Implant Programming (IGCIP)Experimental Treatment1 Intervention
Cochlear implant programming using IGCIP.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Findings from Research

The proposed image-guided cochlear implant programming (IGCIP) system uses CT images to identify and reduce cross-electrode neural stimulation overlap, leading to significantly improved hearing outcomes for patients with cochlear implants.
An automated technique for selecting electrode configurations has been developed, which performs as well as previous methods but is more generic and requires fewer parameters, enhancing the efficiency of the programming process.
Selecting electrode configurations for image-guided cochlear implant programming using template matching.Zhang, D., Zhao, Y., Noble, JH., et al.[2020]

References

Initial Results With Image-guided Cochlear Implant Programming in Children. [2022]
Image-Guided Cochlear Implant Programming: A Systematic Review and Meta-analysis. [2023]
Results of Postoperative, CT-based, Electrode Deactivation on Hearing in Prelingually Deafened Adult Cochlear Implant Recipients. [2022]
Selecting electrode configurations for image-guided cochlear implant programming using template matching. [2020]
Image-guidance enables new methods for customizing cochlear implant stimulation strategies. [2022]
Forces and trauma associated with minimally invasive image-guided cochlear implantation. [2022]
The accuracy of image-based safety analysis for robotic cochlear implantation. [2020]
Statistical shape model segmentation and frequency mapping of cochlear implant stimulation targets in CT. [2021]
Evaluation of a high-resolution patient-specific model of the electrically stimulated cochlea. [2020]
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