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Pediatric Image-Guided Cochlear Implant Programming

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ClinicalTrials.gov Identifier: NCT03886168
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
René Gifford, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Cochlear Implant Other: Signal processing intervention of a biomedical device Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy
Actual Study Start Date : June 30, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate IGCIP
Immediate signal processing intervention of a biomedical device
Other: Signal processing intervention of a biomedical device
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.

Active Comparator: Deferred IGCIP
Delayed signal processing intervention of a biomedical device
Other: Signal processing intervention of a biomedical device
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.




Primary Outcome Measures :
  1. Spectral resolution (spectral modulation detection or SMD) [ Time Frame: 6 months post intervention ]
    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.


Secondary Outcome Measures :
  1. Temporal resolution (sinusoidal amplitude modulation (SAM) detection [ Time Frame: 6 months post intervention ]
    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).


Other Outcome Measures:
  1. Spectro-temporal modulation (STM) [ Time Frame: 6 months post intervention ]
    The spectro-temporal modulation (STM) task will use a 3-interval, 2-alternative forced-choice procedure. STM sensitivity will be measured using a broadband stimulus that has both spectral (1-cycle per octave) and temporal modulation (4- or 32-Hz SAM). The investigators will use a 2-down, 1-up tracking procedure to track 70.7% correct on the psychometric function for all measures. STM threshold will be expressed in spectral modulation depth (in dB) for each of the temporal modulation rates tested.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 6 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 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886168


Contacts
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Contact: Linsey Sunderhaus, AuD 615-936-7066 linsey.sunderhaus@vumc.org
Contact: Rene Gifford, PhD 615-936-5000 rene.gifford@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Rene Gifford, PhD Vanderbilt University Medical Center
Principal Investigator: Stephen Camarata, PhD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by René Gifford, Vanderbilt University Medical Center:
Study Protocol  [PDF] January 9, 2019
Statistical Analysis Plan  [PDF] January 9, 2019


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Responsible Party: René Gifford, Professor, Hearing and Speech Sciences Vanderbilt University Medical Center Director, Cochlear Implant Program Vanderbilt Bill Wilkerson Center, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03886168     History of Changes
Other Study ID Numbers: 190095
1R01DC017683-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by René Gifford, Vanderbilt University Medical Center:
Pediatric Hearing Loss