CT Guided CI Programming

NCT04506424 | Completed

• 1 other identifier: 15-17575
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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). 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)

Study Arms (1)

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.

Other: CT Guided Cochlear Implant Programming

Interventions

CT Guided Cochlear Implant Programming OTHER

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.

CT-Based Program for First Year of CI Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (2)

• 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.

  PMID: 27273394 BACKGROUND

• Jiam 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.

  PMID: 30477013 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles J Limb, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Melanie L Gilbert, AuD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2021
• Primary Completion: April 8, 2024
• Study Completion: April 8, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data and materials will become available after the corresponding manuscript has completed a peer review process and is accepted for publication.
• Access Criteria: Publicly available

Locations

US (1)