<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04506424</url>
  </required_header>
  <id_info>
    <org_study_id>15-17575</org_study_id>
    <nct_id>NCT04506424</nct_id>
  </id_info>
  <brief_title>CT Guided CI Programming</brief_title>
  <official_title>High Resolution CT Guided Cochlear Implant Programming</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current standard of care for cochlear implants (CI) does not address the significant&#xD;
      pitch-place mismatch that is inherent in cochlear implantation (see detailed description&#xD;
      below). The present study uses postoperative Flat Panel (higher resolution than standard) CT&#xD;
      imaging to measure where CI electrodes sit within an individual's cochlea; doing so allows&#xD;
      for more accurate frequency mapping (and thus pitch perception). The hypothesis of this study&#xD;
      is that long-term (1 year) use of CT image-based frequency maps, beginning on the first day&#xD;
      of CI activation, will improve user performance in the areas of speech and music perception,&#xD;
      as compared to the use of default programming settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pitch perception is a fundamental component of how humans process sound. Individuals who use&#xD;
      cochlear implants (CIs), surgically implanted devices which are able to restore a limited&#xD;
      range of hearing, struggle with pitch perception for a variety of reasons. Although CIs can&#xD;
      often restore the ability to hear speech from a single talker in quiet, perception of more&#xD;
      complex auditory stimuli like music is severely limited. CI users often report music as being&#xD;
      difficult, even displeasing, to listen to. These experiences can be immensely frustrating,&#xD;
      especially for people who experience deafness later in life and have built strong emotional&#xD;
      attachments to music, such as musicians or audiophiles.&#xD;
&#xD;
      Cochlear implant programming (also called &quot;mapping&quot;) is done using a set of&#xD;
      generally-accepted default settings without taking into account individual differences of&#xD;
      precisely where CI electrodes are physically located in the cochlea. For this reason, CI&#xD;
      users commonly experience a place-pitch mismatch between the stimulation by an electrode in&#xD;
      response to a given frequency and the actual frequency specified by the original cochlear&#xD;
      location. CI users vary widely in their ability to adapt to place-pitch mismatch; some adapt&#xD;
      completely, others partially, and others not at all. The length of time in which an&#xD;
      individual takes to adapt is also highly variable. Bilateral CI users may have differing&#xD;
      adaptation between ears, leading to distortion of sound localization and speech in noise&#xD;
      perception abilities.&#xD;
&#xD;
      Flat Panel Computed Tomography (FPCT) is an imaging technique that consistently produces high&#xD;
      quality images with identification of the delicate cochlear structures and the cochlear&#xD;
      implant (CI) electrode contacts. FPCT imaging of the cochlea, combined with 3D curved&#xD;
      multiplanar reconstruction (MPR) software, has been shown to yield reliable cochlear duct&#xD;
      length measurements. With these resources, measurements of cochlear length and determination&#xD;
      of intracochlear electrode location relative to standardized cochlear landmarks can be&#xD;
      produced. These data are then utilized to create individualized frequency allocation tables&#xD;
      relevant to the actual physical location of CI electrode contacts.&#xD;
&#xD;
      In this study, FPCT imaging, 3D curved MPR, and applied mathematics are used to quantify the&#xD;
      difference between theoretical and actual electrode contact placement with respect to&#xD;
      pitch-place mapping. Previous results have revealed significant deviations between predicted&#xD;
      and programmed characteristic frequencies, which are relevant for accurate speech, pitch, and&#xD;
      music perception. The goal of the study is to gather FPCT scans on a cohort of 20 new CI&#xD;
      recipients, and characterize the impact of long-term (1 year) personalized pitch-place maps&#xD;
      on a battery of speech and music metrics. The performance with the FPCT-based programs will&#xD;
      then be compared to performance using the manufacturer default settings.&#xD;
&#xD;
      The novel aspect of this study involves working with newly implanted CI recipients and&#xD;
      programming these patients with custom CT-based programs. More specifically, CT-based&#xD;
      programs will be given to new CI recipients before any acclimation or programming of clinical&#xD;
      default maps occur. This differentiates the study from prior ones, as CT-based programming&#xD;
      has only been investigated in populations who have already used clinical default maps for&#xD;
      some substantial period of time (e.g. for 3 months, 5 years, etc.). Participants will&#xD;
      participate in a series of testing sessions to evaluate their speech and music perception&#xD;
      abilities over the course of the study. At the end of the study, participants will be allowed&#xD;
      to keep their preferred listening programs (i.e., experimental and/or default program).&#xD;
&#xD;
      The researcher team hypothesizes that bypassing the use of a clinical-based map is imperative&#xD;
      to fully understanding the effects of CT-based programming, as those who have already used&#xD;
      clinical default programs demonstrate much higher degrees of place-pitch mismatch at&#xD;
      baseline. By providing a new CI recipient with a custom CT-based program on their very first&#xD;
      day of electrical hearing (CI activation), there is a unique and novel opportunity to&#xD;
      minimize pitch-place mismatch from the outset, and to bypass the period of time that the vast&#xD;
      majority of CI recipients have when first adapting to a clinical default program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2021</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>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.&#xD;
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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)</time_frame>
    <description>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).&#xD;
From CI activation until ~12 months post-activation the participant will use the CT-based program. At that time the participant will &quot;switchover&quot; to the clinical default program, which will be used for ~1 month.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Cochlear Implants</condition>
  <condition>Hearing Loss</condition>
  <condition>Amusia</condition>
  <arm_group>
    <arm_group_label>CT-Based Program for First Year of CI Use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Flat Panel CT scan will take place after a CI has been implanted and prior to the CI device activation.&#xD;
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).&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT Guided Cochlear Implant Programming</intervention_name>
    <description>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.</description>
    <arm_group_label>CT-Based Program for First Year of CI Use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has or plans to have a MED-EL cochlear implant (CI)&#xD;
&#xD;
          -  Has not yet had their CI activated&#xD;
&#xD;
          -  Be able and willing to participate in all of the research appointments for follow-up&#xD;
             testing (e.g., 1, 3, 6, 12, and 13 months post-CI activation)&#xD;
&#xD;
          -  Be willing to use the CI full-time (during waking hours) for 13 months post-activation&#xD;
&#xD;
          -  Is able to speak and read American English&#xD;
&#xD;
          -  Uses oral/aural communication as primary communication modality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intra-cochlear electrodes known to be open or short-circuits&#xD;
&#xD;
          -  Partially-inserted CI with fewer than 10 intra-cochlear electrodes&#xD;
&#xD;
          -  Any concomitant condition(s) that may affect performance on speech and music test&#xD;
             battery (e.g., cognitive impairment)&#xD;
&#xD;
          -  Atypical cochlear anatomy (e.g., fewer than 2 turns of the cochlea)&#xD;
&#xD;
          -  Pregnancy (a contraindication for CT scan)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles J Limb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melanie L Gilbert, AuD</last_name>
    <role>Study Director</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27273394</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30477013</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Music perception</keyword>
  <keyword>Place-pitch mismatch</keyword>
  <keyword>Place coding</keyword>
  <keyword>Cochlear duct length</keyword>
  <keyword>Flat panel computed tomography</keyword>
  <keyword>Cochlear implant programming</keyword>
  <keyword>Frequency allocation table</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data/results from participants of this study will be de-identified prior to publication. Data and materials from this study will be uploaded to the repository provided by the Library of the University of California, San Francisco (Dryad).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data and materials will become available after the corresponding manuscript has completed a peer review process and is accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Publicly available</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04506424
org study id: 15-17575
nct id: NCT04506424
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Pitch perception is a fundamental component of how humans process sound. Individuals who use
      cochlear implants (CIs), surgically implanted devices which are able to restore a limited
      range of hearing, struggle with pitch perception for a variety of reasons. Although CIs can
      often restore the ability to hear speech from a single talker in quiet, perception of more
      complex auditory stimuli like music is severely limited. CI users often report music as being
      difficult, even displeasing, to listen to. These experiences can be immensely frustrating,
      especially for people who experience deafness later in life and have built strong emotional
      attachments to music, such as musicians or audiophiles.

      Cochlear implant programming (also called "mapping") is done using a set of
      generally-accepted default settings without taking into account individual differences of
      precisely where CI electrodes are physically located in the cochlea. For this reason, CI
      users commonly experience a place-pitch mismatch between the stimulation by an electrode in
      response to a given frequency and the actual frequency specified by the original cochlear
      location. CI users vary widely in their ability to adapt to place-pitch mismatch; some adapt
      completely, others partially, and others not at all. The length of time in which an
      individual takes to adapt is also highly variable. Bilateral CI users may have differing
      adaptation between ears, leading to distortion of sound localization and speech in noise
      perception abilities.

      Flat Panel Computed Tomography (FPCT) is an imaging technique that consistently produces high
      quality images with identification of the delicate cochlear structures and the cochlear
      implant (CI) electrode contacts. FPCT imaging of the cochlea, combined with 3D curved
      multiplanar reconstruction (MPR) software, has been shown to yield reliable cochlear duct
      length measurements. With these resources, measurements of cochlear length and determination
      of intracochlear electrode location relative to standardized cochlear landmarks can be
      produced. These data are then utilized to create individualized frequency allocation tables
      relevant to the actual physical location of CI electrode contacts.

      In this study, FPCT imaging, 3D curved MPR, and applied mathematics are used to quantify the
      difference between theoretical and actual electrode contact placement with respect to
      pitch-place mapping. Previous results have revealed significant deviations between predicted
      and programmed characteristic frequencies, which are relevant for accurate speech, pitch, and
      music perception. The goal of the study is to gather FPCT scans on a cohort of 20 new CI
      recipients, and characterize the impact of long-term (1 year) personalized pitch-place maps
      on a battery of speech and music metrics. The performance with the FPCT-based programs will
      then be compared to performance using the manufacturer default settings.

      The novel aspect of this study involves working with newly implanted CI recipients and
      programming these patients with custom CT-based programs. More specifically, CT-based
      programs will be given to new CI recipients before any acclimation or programming of clinical
      default maps occur. This differentiates the study from prior ones, as CT-based programming
      has only been investigated in populations who have already used clinical default maps for
      some substantial period of time (e.g. for 3 months, 5 years, etc.). Participants will
      participate in a series of testing sessions to evaluate their speech and music perception
      abilities over the course of the study. At the end of the study, participants will be allowed
      to keep their preferred listening programs (i.e., experimental and/or default program).

      The researcher team hypothesizes that bypassing the use of a clinical-based map is imperative
      to fully understanding the effects of CT-based programming, as those who have already used
      clinical default programs demonstrate much higher degrees of place-pitch mismatch at
      baseline. By providing a new CI recipient with a custom CT-based program on their very first
      day of electrical hearing (CI activation), there is a unique and novel opportunity to
      minimize pitch-place mismatch from the outset, and to bypass the period of time that the vast
      majority of CI recipients have when first adapting to a clinical default program.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 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.
primary purpose: Treatment
masking: None (Open Label)
measure: 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)
time frame: Baseline (12 months post-activation) to 1 month post-switchover (13 months post-activation)
description: 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.
arm group label: CT-Based Program for First Year of CI Use
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: CT Guided Cochlear Implant Programming
description: 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.
arm group label: CT-Based Program for First Year of CI Use
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles J Limb, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Melanie L Gilbert, AuD
role: Study Director
affiliation: University of California, San Francisco
facility: 
country: United States
citation: 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
citation: 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
responsible party type: Sponsor
mesh term: Hearing Loss
sharing ipd: Yes
ipd description: Data/results from participants of this study will be de-identified prior to publication. Data and materials from this study will be uploaded to the repository provided by the Library of the University of California, San Francisco (Dryad).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data and materials will become available after the corresponding manuscript has completed a peer review process and is accepted for publication.
ipd access criteria: Publicly available