Cochlear ImplantsNCT04506424
CT Guided CI Programming
A study testing CT Guided Cochlear Implant Programming in people with Cochlear Implants and Hearing Loss, run by University of California, San Francisco at 1 site in United States.
Trial summary
The current standard of care for cochlear implants (CI) does not address the significant pitch-place mismatch that is inherent in cochlear implantation (see detailed description below). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants, Hearing Loss, Amusia
- What is being tested?
- CT Guided Cochlear Implant Programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 8 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has or plans to have a MED-EL cochlear implant (CI)
- Has not yet had their CI activated
- Be able and willing to participate in all of the research appointments for follow-up testing (e.g., 1, 3, 6, 12, and 13 months post-CI activation)
- Be willing to use the CI full-time (during waking hours) for 13 months post-activation
- Is able to speak and read American English
- Uses oral/aural communication as primary communication modality
Who cannot join
- Intra-cochlear electrodes known to be open or short-circuits
- Partially-inserted CI with fewer than 10 intra-cochlear electrodes
- Any concomitant condition(s) that may affect performance on speech and music test battery (e.g., cognitive impairment)
- Atypical cochlear anatomy (e.g., fewer than 2 turns of the cochlea)
- Pregnancy (a contraindication for CT scan)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: High Resolution CT Guided Cochlear Implant Programming
The current standard of care for cochlear implants (CI) does not address the significant pitch-place mismatch that is inherent in cochlear implantation (see detailed description below). The present study uses postoperative Flat Panel (higher resolution than standard) CT imaging to measure where CI electrodes sit within an individual's cochlea; doing so allows for more accurate frequency mapping (and thus pitch perception). The hypothesis of this study is that long-term (1 year) use of CT image-based frequency maps, beginning on the first day of CI activation, will improve user performance in the areas of speech and music perception, as compared to the use of default programming settings.
Read the detailed description
Pitch perception is a fundamental component of how humans process sound. Individuals who use cochlear implants (CIs), surgically implanted devices which are able to restore a limited range of hearing, struggle with pitch perception for a variety of reasons. Although CIs can often restore the ability to hear speech from a single talker in quiet, perception of more complex auditory stimuli like music is severely limited. CI users often report music as being difficult, even displeasing, to listen to. These experiences can be immensely frustrating, especially for people who experience deafness later in life and have built strong emotional attachments to music, such as musicians or audiophiles.
Cochlear implant programming (also called "mapping") is done using a set of generally-accepted default settings without taking into account individual differences of precisely where CI electrodes are physically located in the cochlea. For this reason, CI users commonly experience a place-pitch mismatch between the stimulation by an electrode in response to a given frequency and the actual frequency specified by the original cochlear location. CI users vary widely in their ability to adapt to place-pitch mismatch; some adapt completely, others partially, and others not at all. The length of time in which an individual takes to adapt is also highly variable. Bilateral CI users may have differing adaptation between ears, leading to distortion of sound localization and speech in noise perception abilities.
Flat Panel Computed Tomography (FPCT) is an imaging technique that consistently produces high quality images with identification of the delicate cochlear structures and the cochlear implant (CI) electrode contacts. FPCT imaging of the cochlea, combined with 3D curved multiplanar reconstruction (MPR) software, has been shown to yield reliable cochlear duct length measurements. With these resources, measurements of cochlear length and determination of intracochlear electrode location relative to standardized cochlear landmarks can be produced. These data are then utilized to create individualized frequency allocation tables relevant to the actual physical location of CI electrode contacts.
In this study, FPCT imaging, 3D curved MPR, and applied mathematics are used to quantify the difference between theoretical and actual electrode contact placement with respect to pitch-place mapping. Previous results have revealed significant deviations between predicted and programmed characteristic frequencies, which are relevant for accurate speech, pitch, and music perception. The goal of the study is to gather FPCT scans on a cohort of 20 new CI recipients, and characterize the impact of long-term (1 year) personalized pitch-place maps on a battery of speech and music metrics. The performance with the FPCT-based programs will then be compared to performance using the manufacturer default settings.
The novel aspect of this study involves working with newly implanted CI recipients and programming these patients with custom CT-based programs. More specifically, CT-based programs will be given to new CI recipients before any acclimation or programming of clinical default maps occur. This differentiates the study from prior ones, as CT-based programming has only been investigated in populations who have already used clinical default maps for some substantial period of time (e.g. for 3 months, 5 years, etc.). Participants will participate in a series of testing sessions to evaluate their speech and music perception abilities over the course of the study. At the end of the study, participants will be allowed to keep their preferred listening programs (i.e., experimental and/or default program).
The researcher team hypothesizes that bypassing the use of a clinical-based map is imperative to fully understanding the effects of CT-based programming, as those who have already used clinical default programs demonstrate much higher degrees of place-pitch mismatch at baseline. By providing a new CI recipient with a custom CT-based program on their very first day of electrical hearing (CI activation), there is a unique and novel opportunity to minimize pitch-place mismatch from the outset, and to bypass the period of time that the vast majority of CI recipients have when first adapting to a clinical default program.
- Conditions
- Cochlear Implants, Hearing Loss, Amusia
- Being tested
- CT Guided Cochlear Implant Programming
- Keywords
- Music perception, Place-pitch mismatch, Place coding, Cochlear duct length, Flat panel computed tomography, Cochlear implant programming, Frequency allocation table
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Guided Cochlear Implant ProgrammingOther
Flat Panel (high resolution) CT scans of the temporal bones, including the inner ears, will be obtained. The research team will use the scans to generate custom cochlear implant (CI) programs for use by the participants.
| Study group | Role | What they receive |
|---|---|---|
| CT-Based Program for First Year of CI Use | Experimental | The Flat Panel CT scan will take place after a CI has been implanted and prior to the CI device activation.
The CI device will be activated using a CT-based program. The participant may continue to use this program for 1 year. Speech and music perception abilities will be monitored at regular intervals (approx. at 1, 3, 6, and 12 months post-activation).
After the 1 year of experimental program use, the participant may be switched over to a program that uses only the clinical default settings for 1 month; after which the participant will again complete the speech and music test battery.
At the end of the 13 month study the participant may choose whether to use the CT-based program or the clinical default program moving forward. Receives: Other: CT Guided Cochlear Implant Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover)
- The CNC word test consists of lists of monosyllabic (single syllable) words with equal phonemic distribution across lists. There are 50 words per list. Performance is calculated based on percentage of words correct (from 0 to 100) and/or percentage of phonemes correct (from 0 to 100).
- From CI activation until ~12 months post-activation the participant will use the CT-based program. At that time the participant will "switchover" to the clinical default program, which will be used for ~1 month.
Measured: Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2021
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo a Flat Panel (high resolution) CT scan of the temporal bones, including the inner ear structures. The research team will make measurements of the cochleas from the CT scans, including cochlear duct length and depth of CI electrodes. The research team will generate custom frequency allocation tables to be used in the experimental programs for the CI. Participants may have the experimental programs uploaded to their CI and use these programs to listen to speech and music stimuli and provide feedback. The participants may be asked to listen to these programs for acute and/or chronic periods of time. Participants may also have their performance on speech and music assessments measured using a clinical default program.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles J Limb, MD, Principal investigator, University of California, San FranciscoMelanie L Gilbert, AuD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506424
- Sponsor's protocol ID
- 15-17575
- Status last verified
- May 2025
- First submitted
- 6 Aug 2020
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data/results from participants of this study will be de-identified prior to publication. Data and materials from this study will be uploaded to the repository provided by the Library of the University of California, San Francisco (Dryad).
Publications
Jiam NT, Pearl MS, Carver C, Limb CJ. Flat-Panel CT Imaging for Individualized Pitch Mapping in Cochlear Implant Users. Otol Neurotol. 2016 Jul;37(6):672-9. doi: 10.1097/MAO.0000000000001060.
PubMed 27273394Jiam NT, Gilbert M, Cooke D, Jiradejvong P, Barrett K, Caldwell M, Limb CJ. Association Between Flat-Panel Computed Tomographic Imaging-Guided Place-Pitch Mapping and Speech and Pitch Perception in Cochlear Implant Users. JAMA Otolaryngol Head Neck Surg. 2019 Feb 1;145(2):109-116. doi: 10.1001/jamaoto.2018.3096.
PubMed 30477013
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution CT Guided Cochlear Implant Programming
- ClinicalTrials.gov ID
- NCT04506424
- Acronym / sponsor ID
- 15-17575
- Conditions
- Cochlear Implants, Hearing Loss, Amusia
- Keywords
- Music perception, Place-pitch mismatch, Place coding, Cochlear duct length, Flat panel computed tomography, Cochlear implant programming, Frequency allocation table
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 10 Aug 2020 (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.
The current standard of care for cochlear implants (CI) does not address the significant pitch-place mismatch that is inherent in cochlear implantation (see detailed description below). The present study uses postoperative Flat Panel (higher resolution than standard) CT imaging to measure where CI electrodes sit within an individual's cochlea; doing so allows for more accurate frequency mapping (and thus pitch perception). The hypothesis of this study is that long-term (1 year) use of CT image-based frequency maps, beginning on the first day of CI activation, will improve user performance in the areas of speech and music perception, as compared to the use of default programming settings.
Detailed description
Pitch perception is a fundamental component of how humans process sound. Individuals who use cochlear implants (CIs), surgically implanted devices which are able to restore a limited range of hearing, struggle with pitch perception for a variety of reasons. Although CIs can often restore the ability to hear speech from a single talker in quiet, perception of more complex auditory stimuli like music is severely limited. CI users often report music as being difficult, even displeasing, to listen to. These experiences can be immensely frustrating, especially for people who experience deafness later in life and have built strong emotional attachments to music, such as musicians or audiophiles.
Cochlear implant programming (also called "mapping") is done using a set of generally-accepted default settings without taking into account individual differences of precisely where CI electrodes are physically located in the cochlea. For this reason, CI users commonly experience a place-pitch mismatch between the stimulation by an electrode in response to a given frequency and the actual frequency specified by the original cochlear location. CI users vary widely in their ability to adapt to place-pitch mismatch; some adapt completely, others partially, and others not at all. The length of time in which an individual takes to adapt is also highly variable. Bilateral CI users may have differing adaptation between ears, leading to distortion of sound localization and speech in noise perception abilities.
Flat Panel Computed Tomography (FPCT) is an imaging technique that consistently produces high quality images with identification of the delicate cochlear structures and the cochlear implant (CI) electrode contacts. FPCT imaging of the cochlea, combined with 3D curved multiplanar reconstruction (MPR) software, has been shown to yield reliable cochlear duct length measurements. With these resources, measurements of cochlear length and determination of intracochlear electrode location relative to standardized cochlear landmarks can be produced. These data are then utilized to create individualized frequency allocation tables relevant to the actual physical location of CI electrode contacts.
In this study, FPCT imaging, 3D curved MPR, and applied mathematics are used to quantify the difference between theoretical and actual electrode contact placement with respect to pitch-place mapping. Previous results have revealed significant deviations between predicted and programmed characteristic frequencies, which are relevant for accurate speech, pitch, and music perception. The goal of the study is to gather FPCT scans on a cohort of 20 new CI recipients, and characterize the impact of long-term (1 year) personalized pitch-place maps on a battery of speech and music metrics. The performance with the FPCT-based programs will then be compared to performance using the manufacturer default settings.
The novel aspect of this study involves working with newly implanted CI recipients and programming these patients with custom CT-based programs. More specifically, CT-based programs will be given to new CI recipients before any acclimation or programming of clinical default maps occur. This differentiates the study from prior ones, as CT-based programming has only been investigated in populations who have already used clinical default maps for some substantial period of time (e.g. for 3 months, 5 years, etc.). Participants will participate in a series of testing sessions to evaluate their speech and music perception abilities over the course of the study. At the end of the study, participants will be allowed to keep their preferred listening programs (i.e., experimental and/or default program).
The researcher team hypothesizes that bypassing the use of a clinical-based map is imperative to fully understanding the effects of CT-based programming, as those who have already used clinical default programs demonstrate much higher degrees of place-pitch mismatch at baseline. By providing a new CI recipient with a custom CT-based program on their very first day of electrical hearing (CI activation), there is a unique and novel opportunity to minimize pitch-place mismatch from the outset, and to bypass the period of time that the vast majority of CI recipients have when first adapting to a clinical default program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo a Flat Panel (high resolution) CT scan of the temporal bones, including the inner ear structures. The research team will make measurements of the cochleas from the CT scans, including cochlear duct length and depth of CI electrodes. The research team will generate custom frequency allocation tables to be used in the experimental programs for the CI. Participants may have the experimental programs uploaded to their CI and use these programs to listen to speech and music stimuli and provide feedback. The participants may be asked to listen to these programs for acute and/or chronic periods of time. Participants may also have their performance on speech and music assessments measured using a clinical default program.
| Arm | Type | Receives |
|---|---|---|
| CT-Based Program for First Year of CI Use | Experimental | Other: CT Guided Cochlear Implant ProgrammingThe Flat Panel CT scan will take place after a CI has been implanted and prior to the CI device activation. The CI device will be activated using a CT-based program. The participant may continue to use this program for 1 year. Speech and music perception abilities will be monitored at regular intervals (approx. at 1, 3, 6, and 12 months post-activation). After the 1 year of experimental program use, the participant may be switched over to a program that uses only the clinical default settings for 1 month; after which the participant will again complete the speech and music test battery. At the end of the 13 month study the participant may choose whether to use the CT-based program or the clinical default program moving forward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has or plans to have a MED-EL cochlear implant (CI)
- Has not yet had their CI activated
- Be able and willing to participate in all of the research appointments for follow-up testing (e.g., 1, 3, 6, 12, and 13 months post-CI activation)
- Be willing to use the CI full-time (during waking hours) for 13 months post-activation
- Is able to speak and read American English
Key exclusion criteria (5 listed)
- Intra-cochlear electrodes known to be open or short-circuits
- Partially-inserted CI with fewer than 10 intra-cochlear electrodes
- Any concomitant condition(s) that may affect performance on speech and music test battery (e.g., cognitive impairment)
- Atypical cochlear anatomy (e.g., fewer than 2 turns of the cochlea)
- Pregnancy (a contraindication for CT scan)
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 |
|---|---|---|
| CT Guided Cochlear Implant ProgrammingFlat Panel (high resolution) CT scans of the temporal bones, including the inner ears, will be obtained. The research team will use the scans to generate custom cochlear implant (CI) programs for use by the participants. | Other | CT-Based Program for First Year of CI Use |
Primary outcome
Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover)
Time frame: Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)
* The CNC word test consists of lists of monosyllabic (single syllable) words with equal phonemic distribution across lists. There are 50 words per list. Performance is calculated based on percentage of words correct (from 0 to 100) and/or percentage of phonemes correct (from 0 to 100). * From CI activation until ~12 months post-activation the participant will use the CT-based program. At that time the participant will "switchover" to the clinical default program, which will be used for ~1 month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 27273394Jiam NT, Pearl MS, Carver C, Limb CJ. Flat-Panel CT Imaging for Individualized Pitch Mapping in Cochlear Implant Users. Otol Neurotol. 2016 Jul;37(6):672-9. doi: 10.1097/MAO.0000000000001060.
- Background: PubMed 30477013Jiam NT, Gilbert M, Cooke D, Jiradejvong P, Barrett K, Caldwell M, Limb CJ. Association Between Flat-Panel Computed Tomographic Imaging-Guided Place-Pitch Mapping and Speech and Pitch Perception in Cochlear Implant Users. JAMA Otolaryngol Head Neck Surg. 2019 Feb 1;145(2):109-116. doi: 10.1001/jamaoto.2018.3096.
- Individual participant dataSharing planned: Yes. Data/results from participants of this study will be de-identified prior to publication. Data and materials from this study will be uploaded to the repository provided by the Library of the University of California, San Francisco (Dryad).
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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.
Charles J Limb, MD principal investigator
University of California, San Francisco
Melanie L Gilbert, AuD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Guided Cochlear Implant Programming in people with Cochlear Implants and Hearing Loss, run by University of California, San Francisco at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 30 May 2025. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in score on the Consonant-Nucleus-Consonant (CNC) Test between chronic use of the CT-based program (~12 months post-activation) and chronic use of the clinical default program (~1 month post-switchover) (time frame: Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04506424, which also lists 2 linked publications.
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 30 May 2025.