Objective Measures of Cochlear Implant Electrode Position and Function

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cochlear Implants
• Intervention / Treatment: Diagnostic test: SCINSEV and PECAP

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 OQQ
    • Cambridge University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard of Care	Diagnostic test: SCINSEV and PECAP; To measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sophie McKenny
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: Daniele Borsetto, Addenbrookes Hospital, CUH

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (ACTUAL): August 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: electrophysiology; cochlear implant; auditory nerve fibres; extra cochlear electrodes
• Other Study ID Numbers: 285894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No