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Clinical Trials/NCT04987684
NCT04987684
Unknown
N/A

Objective Measures of Cochlear Implant Electrode Position and Function

Sophie McKenny1 site in 1 country30 target enrollmentDecember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cochlear Implants
Sponsor
Sophie McKenny
Enrollment
30
Locations
1
Primary Endpoint
Validation of extra cochlear electrodes
Last Updated
4 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
January 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sophie McKenny
Responsible Party
Sponsor Investigator
Principal Investigator

Sophie McKenny

Clinical Researcher

Cambridge University Hospitals NHS Foundation Trust

Eligibility Criteria

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

Outcomes

Primary Outcomes

Validation of extra cochlear electrodes

Time Frame: 12 months

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.

Secondary Outcomes

  • Pre and post op loudness comparison(12 months)

Study Sites (1)

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