Objective Measures of Cochlear Implant Electrode Position and Function

Cochlear Implants Clinical Trial

Official title:

Objective Measures of Cochlear Implant Electrode Position and Function

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04987684
• Other study ID #: 285894
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 2022

Study information

• Verified date: August 2021
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Sophie McKenny	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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