Clinical trial NCT04987684: Objective Measures of Cochlear Implant Electrode Position and Function
Official title: Objective Measures of Cochlear Implant Electrode Position and Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cochlear Implants
Keywords: cochlear implant
electrophysiology
auditory nerve fibres
extra cochlear electrodes
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2021-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Validation of extra cochlear electrodes
timeFrame: 12 months
Secondary outcomes:
measure: Pre and post op loudness comparison
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
Study officials:
affiliation: Addenbrookes Hospital, CUH
name: Daniele Borsetto
role: PRINCIPAL_INVESTIGATOR
References: