Cochlear ImplantsNCT04987684
Objective Measures of Cochlear Implant Electrode Position and Function
A study testing SCINSEV and PECAP in people with Cochlear Implants, run by Sophie McKenny at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- SCINSEV and PECAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Using medication in a manner that might affect hearing levels
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 OQQ
About this study
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.
Read the 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
- Conditions
- Cochlear Implants
- Being tested
- SCINSEV and PECAP
- Keywords
- cochlear implant, electrophysiology, auditory nerve fibres, extra cochlear electrodes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCINSEV and PECAPDiagnostic test
To measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Not described Receives: Diagnostic Test: SCINSEV and PECAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Dec 2020
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophie McKenny
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor-investigator, Sophie McKenny, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Daniele Borsetto, Principal investigator, Addenbrookes Hospital, CUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987684
- Sponsor's protocol ID
- 285894
- Status last verified
- Aug 2021
- First submitted
- 25 Sep 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measures of Cochlear Implant Electrode Position and Function
- ClinicalTrials.gov ID
- NCT04987684
- Acronym / sponsor ID
- 285894
- Conditions
- Cochlear Implants
- Keywords
- cochlear implant, electrophysiology, auditory nerve fibres, extra cochlear electrodes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sophie McKennyUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Diagnostic Test: SCINSEV and PECAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Using medication in a manner that might affect hearing levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCINSEV and PECAPTo measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear. | Diagnostic test | Standard of Care |
Primary outcome
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.
1 secondary outcome
Pre and post op loudness comparison
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Cochlear Implants
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Recruiting
Pitch Perception and Memory: Deficits and Training
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Active, not recruiting
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
Hearing Loss
Not yet recruitingObservational study
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
Hearing Loss, Hearing Implants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Borsetto principal investigator
Addenbrookes Hospital, CUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCINSEV and PECAP in people with Cochlear Implants, run by Sophie McKenny at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of extra cochlear electrodes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.