Cochlear ImplantNCT03306082
Image-guided Cochlear Implant Programming (IGCIP)
A study testing Image-Guided Cochlear Implant Programming in people with Cochlear Implant, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- Image-Guided Cochlear Implant Programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2015to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 90 years that have undergone diagnostic testing for sensorineural hearing loss and have received a cochlear implant with asymptotic improvement in performance with SOC programming will be considered eligible for the study.
Who cannot join
- Age < 18 years or > 90 years
- Non-English speaking (because our audiological speech testing battery is validated for English speakers)
- Pregnancy which is a contraindication for elective CT scanning and surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. The research team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). The study collects data in a prospective fashion for those CI recipient undergoing IGCIP.
Read the detailed description
Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the number is dependent on the manufacturer of the CI) which cover the entire frequency spectrum of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After implantation, an audiologist individually adjusts stimulation levels of each electrode following which all electrodes are turned on such that the whole frequency spectrum of speech can be appreciated. This is known as "standard of care" (SOC) programming. While postoperative speech understanding is significantly better than preoperative levels, even the best performers complain that the fidelity of natural hearing is not reproduced. Additionally, a significant minority achieves poor outcomes despite normally functioning equipment for reasons that are unknown but likely relate to poor neural survival; however, this cannot be confirmed as postmortem histopathology is required to accurately document spiral ganglion cell count. In recent years much attention has focused on the interface between the cochlear implant electrodes and the auditory neurons they are stimulating. Technological improvements at Vanderbilt in imaging processing have made it possible to determine the location of each electrode array in relationship to the frequency spectrum of the cochlea. Using this information, the investigators have developed a new method of CI programming which they call image-guided cochlear implant programming, or IGCIP in which sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed electrodes are defined as ones for which their neighboring electrodes are in closer proximity to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes, channel interaction is reduced allowing a cleaner signal to be presented to the auditory nerve. The purpose of the study is to prospectively collect audiological outcomes on patients undergoing IGCIP. The investigators hypothesize that CI recipients will perform better with IGCIP as compared to SOC.
Cochlear implant recipients who have reached asymptotic improvement in performance with SOC will be offered enrollment. They will undergo post-operative CT scanning to determine the relationship between the cochlear implant electrodes and the neural interface. Recommendations regarding deactivation of sub-optimally placed electrodes will be communicated to the audiology team who, if in their clinical judgement deems deactivation of these electrodes reasonable, will implement the changes for a 1 month trial. The participant will return at 1 month to have audiological assessment as per the clinical standard of care. Based on these results, which will be shared with the patient, the patient can choose to use IGCIP or SOC for long term cochlear implant programming.
- Conditions
- Cochlear Implant
- Being tested
- Image-Guided Cochlear Implant Programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided Cochlear Implant ProgrammingOther
Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.
| Study group | Role | What they receive |
|---|---|---|
| Image-guided Cochlear Implant Programming (IGCIP) | Experimental | Cochlear implant programming using IGCIP. Receives: Other: Image-Guided Cochlear Implant Programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)
Measured: Month 1 post cochlear implant activation
Secondary outcomes (1)
Minimum Speech Test Battery
Measured: Month 1 post cochlear implant activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start23 Jun 2015
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Prospective Cohort study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Jack Noble, Vanderbilt University
- Investigators
- Jack H. Noble, PhD, Principal investigator, Vanderbilt UniversityRene H. Gifford, PhD, Study chair, Vanderbilt University Medical CenterRobert F. Labadie, MD, PhD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306082
- Sponsor's protocol ID
- 150417
- Other IDs
- R01DC014037
- Status last verified
- Jul 2026
- First submitted
- 4 Oct 2017
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Cochlear Implant Programming (IGCIP)
- ClinicalTrials.gov ID
- NCT03306082
- Acronym / sponsor ID
- 150417
- Conditions
- Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Oct 2017 (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.
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. The research team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). The study collects data in a prospective fashion for those CI recipient undergoing IGCIP.
Detailed description
Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the number is dependent on the manufacturer of the CI) which cover the entire frequency spectrum of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After implantation, an audiologist individually adjusts stimulation levels of each electrode following which all electrodes are turned on such that the whole frequency spectrum of speech can be appreciated. This is known as "standard of care" (SOC) programming. While postoperative speech understanding is significantly better than preoperative levels, even the best performers complain that the fidelity of natural hearing is not reproduced. Additionally, a significant minority achieves poor outcomes despite normally functioning equipment for reasons that are unknown but likely relate to poor neural survival; however, this cannot be confirmed as postmortem histopathology is required to accurately document spiral ganglion cell count. In recent years much attention has focused on the interface between the cochlear implant electrodes and the auditory neurons they are stimulating. Technological improvements at Vanderbilt in imaging processing have made it possible to determine the location of each electrode array in relationship to the frequency spectrum of the cochlea. Using this information, the investigators have developed a new method of CI programming which they call image-guided cochlear implant programming, or IGCIP in which sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed electrodes are defined as ones for which their neighboring electrodes are in closer proximity to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes, channel interaction is reduced allowing a cleaner signal to be presented to the auditory nerve. The purpose of the study is to prospectively collect audiological outcomes on patients undergoing IGCIP. The investigators hypothesize that CI recipients will perform better with IGCIP as compared to SOC.
Cochlear implant recipients who have reached asymptotic improvement in performance with SOC will be offered enrollment. They will undergo post-operative CT scanning to determine the relationship between the cochlear implant electrodes and the neural interface. Recommendations regarding deactivation of sub-optimally placed electrodes will be communicated to the audiology team who, if in their clinical judgement deems deactivation of these electrodes reasonable, will implement the changes for a 1 month trial. The participant will return at 1 month to have audiological assessment as per the clinical standard of care. Based on these results, which will be shared with the patient, the patient can choose to use IGCIP or SOC for long term cochlear implant programming.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort study
| Arm | Type | Receives |
|---|---|---|
| Image-guided Cochlear Implant Programming (IGCIP) | Experimental | Other: Image-Guided Cochlear Implant ProgrammingCochlear implant programming using IGCIP. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 90 years that have undergone diagnostic testing for sensorineural hearing loss and have received a cochlear implant with asymptotic improvement in performance with SOC programming will be considered eligible for the study.
Key exclusion criteria (3 listed)
- Age < 18 years or > 90 years
- Non-English speaking (because our audiological speech testing battery is validated for English speakers)
- Pregnancy which is a contraindication for elective CT scanning and surgery
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 |
|---|---|---|
| Image-Guided Cochlear Implant ProgrammingPost Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant. | Other | Image-guided Cochlear Implant Programming (IGCIP) |
Primary outcome
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)
Time frame: Month 1 post cochlear implant activation
1 secondary outcome
Minimum Speech Test Battery
Time frame: Month 1 post cochlear implant activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
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
Cochlear Implants
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.
Jack H. Noble, PhD principal investigator
Vanderbilt University
Rene H. Gifford, PhD study chair
Vanderbilt University Medical Center
Robert F. Labadie, MD, PhD study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Cochlear Implant Programming in people with Cochlear Implant, run by Vanderbilt University Medical Center 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR) (time frame: Month 1 post cochlear implant activation). 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 3 Aug 2026.