Objective Measures of Cochlear Implant Electrode Position and Function

Study Overview
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Brief Summary
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Recruit adult patients eligible for cochlear Implant surgery. During routine surgery monitor electrode placement with new 'SCINSEV' technique and complete 'PECAPs' on patient to identify if any of the electrodes have misplaced. Follow up with patient after surgery for post operative appointment with same measurements.

Detailed Description
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Cochlear implants (CIs) restore hearing to deaf patients by electrically stimulating the auditory nerve using an array of electrodes inserted into the cochlea (inner ear). All electrodes should be successfully inserted in the cochlea, with each electrode exciting a discrete range of auditory nerve fibers. Our research investigates two exceptions to this ideal situation, both of which impair the participant's ability to clearly hear sounds such as speech. One exception occurs when some electrodes are located outside the cochlea, limiting the amount of information that is conveyed to the brain and potentially causing unwanted side effects. Our research will identify these extra-cochlear electrodes during the CI operation, by stimulating each electrode in turn and recording from all other electrodes. This SCINSEV technique then uses a sophisticated computational method to identify which if any electrodes are out of the cochlea. Even when all electrodes are in the cochlea, however, some may produce broad current spreads, which will blur the perception of sounds. Our second PECAP method measures these instances by stimulating pairs of electrodes and recording the neural responses. It also uses a new computational method, this time so as to calculate the neural spread from each electrode. Both methods use fast, non-invasive, objective measurements that use the built-in capabilities of the implant .The interventions used are very similar to those employed in standard clinical practice, and the results will pave the way for better identification and management of poor hearing by CI patients

Official Title
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Objective Measures of Cochlear Implant Electrode Position and Function

Conditions
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Cochlear Implants

Intervention / Treatment
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* Diagnostic Test: SCINSEV and PECAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing or able to consent to participation in the study Meets normal candidacy requirements for cochlear implantation At least 18 years of age at time of consent being given Patent cochlea as verified by CT or MRI scan No additional complex needs that would prevent study procedures being followed Agreement to participate in the study Exclusion Criteria: Using medication in a manner that might affect hearing levels

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care<br> | Diagnostic Test: SCINSEV and PECAP<br>* To measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of extra cochlear electrodes | Number of extra-cochlear electrodes obtained using our SCINSEV analysis correspond to the actual number of extra-cochlear electrodes observed during different stages of insertion. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre and post op loudness comparison | Numbers of neural dead regions and wide current spread estimated intra-operatively and using equal current per electrode using our PECAP method correspond to those occurring post-operatively and using equal loudness per electrode | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, electrophysiology, auditory nerve fibres, extra cochlear electrodes