Cochlear Implant Clinical Trial
Official title:
Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | Inclusion Criteria: 1. Children aged 4 to 12 years of age 2. Prelingual onset of deafness 3. 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 4. Cochlear implantation prior to 4 years of age 5. Nonverbal cognitive abilities within the typical range 6. No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment 7. Pre-operative CT scan of head performed as standard of care CI work-up 8. Post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed consent Exclusion Criteria: 1. Severe anatomical abnormality(s) of the temporal bone. 2. Onset of moderate-to-profound sensorineural hearing loss after 2 years of age 3. Nonverbal intelligence standard score < 85 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Temporal resolution (sinusoidal amplitude modulation (SAM) detection | The temporal resolution task includes sinusoidal amplitude modulation (SAM) detection with a 3-interval, 2-alternative forced-choice procedure.The participant will discriminate between noises with a flat temporal envelope and sinusoidal amplitude modulation. The investigators will use a broadband stimulus at 65 dB SPL and assess amplitude modulation rates of 4, 32, and 128 Hz. SAM threshold will be expressed in 20 log m (in dB), with m representing the modulation index (0 to 1). | 6 months post intervention |
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