What side effects are associated with this type of intervention?

Common treatments for cochlear implants include standard mapping procedures and the more advanced Image-guided Cochlear Implant Programming (IGCIP). Known side effects of cochlear implant treatments can include wound complications, infections, and device-related issues such as electrode migration or malfunction. Specifically, for IGCIP, which involves deactivating sub-optimally positioned electrodes based on post-operative CT scans, potential side effects may include discomfort during the mapping process and the need for additional adjustments to optimize hearing outcomes. Overall, while these treatments are generally safe, patients may experience some minor complications that can be managed with appropriate medical care.

What prior FDA approvals exist?

FDA-approved cochlear implants typically involve devices with multiple electrodes (ranging from 12 to 22) that are activated and adjusted post-surgery to optimize hearing. The standard mapping procedure does not usually consider the physical location of electrodes relative to the neural interface. The Image-guided Cochlear Implant Programming (IGCIP) trial represents an advancement by using post-operative CT scans to customize electrode activation, potentially improving outcomes by deactivating sub-optimally positioned electrodes. While specific drugs are not typically involved in the mapping process, the focus remains on optimizing the electrical stimulation provided by the implant.

What other types of research exist?

Promising novel alternatives to IGCIP for cochlear implant patients include: 1) Electrocochleography (ECochG)-guided programming, which uses intraoperative ECochG signals to optimize electrode placement and stimulation parameters; 2) Machine learning algorithms for personalized mapping, which analyze patient-specific data to predict optimal settings; and 3) Auditory nerve response telemetry (ART)-based programming, which adjusts settings based on real-time feedback from the auditory nerve's response to electrical stimulation.

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Image-Guided Programming for Cochlear Implants

N/A

Waitlist Available

Led By Jack H. Noble, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Age < 18 years or > 90 years

Pregnancy which is a contraindication for elective CT scanning and surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, side effects may include discomfort from additional CT scans and potential auditory changes due to electrode deactivation as part of IGCIP.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 90.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Image-guided Cochlear Implant Programming (IGCIP)Experimental Treatment1 Intervention

Cochlear implant programming using IGCIP.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cochlear implants work by directly stimulating the auditory nerve with electrical signals, bypassing damaged parts of the inner ear. Traditional mapping of cochlear implants involves activating and adjusting each electrode to optimize hearing. Image-guided Cochlear Implant Programming (IGCIP) enhances this process by using post-operative CT scans to determine the precise location of each electrode relative to the neural interface. This allows for the deactivation of sub-optimally positioned electrodes, potentially improving auditory outcomes. This customized approach is significant for patients as it aims to maximize the effectiveness of the implant, leading to better hearing performance and overall quality of life.

First-in-human intracochlear application of human stromal cell-derived extracellular vesicles.[Cochlear implant application with postlingually deaf patients].Glial cell line-derived neurotrophic factor and chronic electrical stimulation prevent VIII cranial nerve degeneration following denervation.