Pediatric Image-Guided Cochlear Implant Programming

NCT03886168 | Completed

• 2 other identifiers: 1900951R01DC017683-01A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss; however, many pediatric CI recipients display persistent speech and language disorders despite early implantation and associated speech/language intervention. Cochlear implants are programmed 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 (SOC) mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our 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). This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients.

Conditions

Cochlear Implant

Keywords

Pediatric Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Spectral resolution (spectral modulation detection or SMD)

  The spectral modulation detection (SMD) task of spectral resolution will use a 3-interval, 2-alternative forced-choice procedure. The participant will discriminate between flat-spectrum and spectrally-modulated noise presented at 65 dB SPL. The investigators will use a broadband stimulus and assess spectral modulation rates of 0.5 and 1.0 cycle per octave. Threshold will be expressed in modulation depth (in dB) for each modulation rate tested.

  6 months post intervention

Secondary Outcomes (1)

• Temporal resolution (sinusoidal amplitude modulation (SAM) detection

  6 months post intervention

Study Arms (2)

Immediate IGCIP

EXPERIMENTAL

Immediate signal processing intervention of a biomedical device

Other: Signal processing intervention of a biomedical device

Deferred IGCIP

ACTIVE COMPARATOR

Delayed signal processing intervention of a biomedical device

Other: Signal processing intervention of a biomedical device

Interventions

Signal processing intervention of a biomedical device OTHER

This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.

Deferred IGCIP; Immediate IGCIP

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 12 years of age
• Prelingual onset of deafness
• At least one CI and bilateral moderate to profound sensorineural hearing loss
• for children with a single CI, audiometric thresholds in the non-CI ear must be consistent with at least a moderate to profound sensorineural hearing loss
• Cochlear implantation prior to 4 years of age
• Nonverbal cognitive abilities within the typical range
• No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment
• Pre-operative CT scan of head performed as standard of care CI work-up
• Post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed consent

You may not qualify if:

• Severe anatomical abnormality(s) of the temporal bone.
• Onset of moderate-to-profound sensorineural hearing loss after 2 years of age
• Nonverbal intelligence standard score \< 85

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• DeFreese, A., Camarata, S., Sunderhaus, L., Holder, J., Berg, K., Lighterink, M., & Gifford, R. (2024). The impact of spectral and temporal processing on speech recognition in children with cochlear implants. Scientific reports, 14(1), 14094.

  RESULT

• Camarata S, Lighterink M, Sunderhaus L, Labadie R, Gifford R. Phonological processing, oral language abilities, and reading comprehension in children with cochlear implants. Sci Rep. 2026 Jan 10;15(1):45800. doi: 10.1038/s41598-025-22358-8.

  PMID: 41519852 RESULT

Study Officials

• Rene Gifford, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Stephen Camarata, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A randomization schedule will be generated by study statistician and provided to PIs prior to study commencement. To ensure equal numbers of participants in each arm, a computer-generated, permuted blocking algorithm (blocks of 4 participants) will be used to develop the schedule. The schedule will be password protected and saved on an encrypted server housed at the Vanderbilt Bill Wilkerson Center. The investigators will be using identical procedures for all participants regardless of arm to which the participants randomize. Both the experimenters and the participants will be blinded. The experimenters will be notified of the randomization for a given participant on the day of the baseline visit. Only the PIs and study statistician will know whether the participant is in the intervention or deferred waitlist group until the end of the study. Neither PI nor study statistician will be personally administering assessments nor scoring tests for the participants.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Hearing and Speech Sciences Vanderbilt University Medical Center Director, Cochlear Implant Program Vanderbilt Bill Wilkerson Center

Model Details: The total sample (n = 72) will be randomly assigned to either immediate IGCIP intervention (n = 36) or a deferred waitlist condition (n = 36). Both groups will be monitored for 24 months, with testing at time 1 (baseline), time 2 (2 months), time 3 (6 months), and time 4 (12 months). After 12 months, the deferred treatment group will receive the IGCIP intervention. Testing will then continue at time 5 (14 months), time 6 (18 months), and time 7 (24 months). At the conclusion of the project, the investigators will have 12 months of data on untreated growth, 12 months data of treated growth in the deferred treatment group, and 24 months of growth in the immediate IGCIP treatment group.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: June 30, 2019
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)