Objective Measures of Cochlear Implant Electrode Position and Function

Not Applicable

• Conditions: Cochlear Implants
• Interventions: Diagnostic Test: SCINSEV and PECAP

• Registration Number: NCT04987684
• Lead Sponsor: Sophie McKenny

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

Study Timeline

• Study First Submitted: 2020-09-25
• Study Start: 2020-12-01
• Study First Submitted QC: 2021-07-28
• Status Verified: 2021-08
• Study First Posted: 2021-08-03
• Last Update Submitted: 2021-08-19
• Last Update Posted: 2021-08-25
• Primary Completion: 2021-10
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of Care	SCINSEV and PECAP	-

Primary Outcome Measures

Name	Time	Method
Validation of extra cochlear electrodes	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 Outcome Measures

Name	Time	Method
Pre and post op loudness comparison	12 months	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

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom