<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/NCT03306082</url>
  </required_header>
  <id_info>
    <org_study_id>150417</org_study_id>
    <secondary_id>R01DC014037</secondary_id>
    <nct_id>NCT03306082</nct_id>
  </id_info>
  <brief_title>Image-guided Cochlear Implant Programming (IGCIP)</brief_title>
  <official_title>Image-guided Cochlear Implant Programming (IGCIP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Cochlear implants are surgically implanted devices which restore the ability to hear to the&#xD;
      hearing impaired. While remarkably successful, even in the best of performers restoration of&#xD;
      hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,&#xD;
      cochlear implants are activated via mapping - a process in which each individual electrode&#xD;
      (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the&#xD;
      stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At&#xD;
      present, this standard of care mapping procedure is performed without knowledge of the&#xD;
      physical location between the cochlear implant electrodes and the neural interface. The&#xD;
      research team has developed a new method of mapping using post-operative CT scans and image&#xD;
      processing to specify the physical relationship between the cochlear implant electrodes and&#xD;
      the neural interface allowing customized mapping. Using this information, the investigators&#xD;
      deactivate sub-optimally positioned electrodes. The investigators term this &quot;Image-guided&#xD;
      Cochlear Implant Programming&quot; (IGCIP). The study collects data in a prospective fashion for&#xD;
      those CI recipient undergoing IGCIP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the&#xD;
      hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the&#xD;
      number is dependent on the manufacturer of the CI) which cover the entire frequency spectrum&#xD;
      of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After&#xD;
      implantation, an audiologist individually adjusts stimulation levels of each electrode&#xD;
      following which all electrodes are turned on such that the whole frequency spectrum of speech&#xD;
      can be appreciated. This is known as &quot;standard of care&quot; (SOC) programming. While&#xD;
      postoperative speech understanding is significantly better than preoperative levels, even the&#xD;
      best performers complain that the fidelity of natural hearing is not reproduced.&#xD;
      Additionally, a significant minority achieves poor outcomes despite normally functioning&#xD;
      equipment for reasons that are unknown but likely relate to poor neural survival; however,&#xD;
      this cannot be confirmed as postmortem histopathology is required to accurately document&#xD;
      spiral ganglion cell count. In recent years much attention has focused on the interface&#xD;
      between the cochlear implant electrodes and the auditory neurons they are stimulating.&#xD;
      Technological improvements at Vanderbilt in imaging processing have made it possible to&#xD;
      determine the location of each electrode array in relationship to the frequency spectrum of&#xD;
      the cochlea. Using this information, the investigators have developed a new method of CI&#xD;
      programming which they call image-guided cochlear implant programming, or IGCIP in which&#xD;
      sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed&#xD;
      electrodes are defined as ones for which their neighboring electrodes are in closer proximity&#xD;
      to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes,&#xD;
      channel interaction is reduced allowing a cleaner signal to be presented to the auditory&#xD;
      nerve. The purpose of the study is to prospectively collect audiological outcomes on patients&#xD;
      undergoing IGCIP. The investigators hypothesize that CI recipients will perform better with&#xD;
      IGCIP as compared to SOC.&#xD;
&#xD;
      Cochlear implant recipients who have reached asymptotic improvement in performance with SOC&#xD;
      will be offered enrollment. They will undergo post-operative CT scanning to determine the&#xD;
      relationship between the cochlear implant electrodes and the neural interface.&#xD;
      Recommendations regarding deactivation of sub-optimally placed electrodes will be&#xD;
      communicated to the audiology team who, if in their clinical judgement deems deactivation of&#xD;
      these electrodes reasonable, will implement the changes for a 1 month trial. The participant&#xD;
      will return at 1 month to have audiological assessment as per the clinical standard of care.&#xD;
      Based on these results, which will be shared with the patient, the patient can choose to use&#xD;
      IGCIP or SOC for long term cochlear implant programming.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 23, 2015</start_date>
  <completion_date type="Anticipated">May 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2025</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>Prospective Cohort study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)</measure>
    <time_frame>Month 1 post cochlear implant activation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimum Speech Test Battery</measure>
    <time_frame>Month 1 post cochlear implant activation</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cochlear Implant</condition>
  <arm_group>
    <arm_group_label>Image-guided Cochlear Implant Programming (IGCIP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cochlear implant programming using IGCIP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Image-Guided Cochlear Implant Programming</intervention_name>
    <description>Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.</description>
    <arm_group_label>Image-guided Cochlear Implant Programming (IGCIP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 to 90 years that have undergone diagnostic testing for sensorineural&#xD;
             hearing loss and have received a cochlear implant with asymptotic improvement in&#xD;
             performance with SOC programming will be considered eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years or &gt; 90 years&#xD;
&#xD;
          -  Non-English speaking (because our audiological speech testing battery is validated for&#xD;
             English speakers)&#xD;
&#xD;
          -  Pregnancy which is a contraindication for elective CT scanning and surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack H. Noble, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rene H. Gifford, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert F. Labadie, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Jack Noble</investigator_full_name>
    <investigator_title>Research Assistant Professor, Electrical Engineering and Computer Science</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03306082
org study id: 150417
secondary id: R01DC014037
nct id: NCT03306082
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cochlear implants are surgically implanted devices which restore the ability to hear to the
      hearing impaired. While remarkably successful, even in the best of performers restoration of
      hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery,
      cochlear implants are activated 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 mapping procedure is performed without knowledge of the
      physical location between the cochlear implant electrodes and the neural interface. The
      research 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). The study collects data in a prospective fashion for
      those CI recipient undergoing IGCIP.
Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the
      hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the
      number is dependent on the manufacturer of the CI) which cover the entire frequency spectrum
      of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After
      implantation, an audiologist individually adjusts stimulation levels of each electrode
      following which all electrodes are turned on such that the whole frequency spectrum of speech
      can be appreciated. This is known as "standard of care" (SOC) programming. While
      postoperative speech understanding is significantly better than preoperative levels, even the
      best performers complain that the fidelity of natural hearing is not reproduced.
      Additionally, a significant minority achieves poor outcomes despite normally functioning
      equipment for reasons that are unknown but likely relate to poor neural survival; however,
      this cannot be confirmed as postmortem histopathology is required to accurately document
      spiral ganglion cell count. In recent years much attention has focused on the interface
      between the cochlear implant electrodes and the auditory neurons they are stimulating.
      Technological improvements at Vanderbilt in imaging processing have made it possible to
      determine the location of each electrode array in relationship to the frequency spectrum of
      the cochlea. Using this information, the investigators have developed a new method of CI
      programming which they call image-guided cochlear implant programming, or IGCIP in which
      sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed
      electrodes are defined as ones for which their neighboring electrodes are in closer proximity
      to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes,
      channel interaction is reduced allowing a cleaner signal to be presented to the auditory
      nerve. The purpose of the study is to prospectively collect audiological outcomes on patients
      undergoing IGCIP. The investigators hypothesize that CI recipients will perform better with
      IGCIP as compared to SOC.

      Cochlear implant recipients who have reached asymptotic improvement in performance with SOC
      will be offered enrollment. They will undergo post-operative CT scanning to determine the
      relationship between the cochlear implant electrodes and the neural interface.
      Recommendations regarding deactivation of sub-optimally placed electrodes will be
      communicated to the audiology team who, if in their clinical judgement deems deactivation of
      these electrodes reasonable, will implement the changes for a 1 month trial. The participant
      will return at 1 month to have audiological assessment as per the clinical standard of care.
      Based on these results, which will be shared with the patient, the patient can choose to use
      IGCIP or SOC for long term cochlear implant programming.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective Cohort study
primary purpose: Treatment
masking: None (Open Label)
measure: AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)
time frame: Month 1 post cochlear implant activation
measure: Minimum Speech Test Battery
time frame: Month 1 post cochlear implant activation
arm group label: Image-guided Cochlear Implant Programming (IGCIP)
arm group type: Experimental
description: Cochlear implant programming using IGCIP.
intervention type: Other
intervention name: Image-Guided Cochlear Implant Programming
description: Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.
arm group label: Image-guided Cochlear Implant Programming (IGCIP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jack H. Noble, PhD
role: Principal Investigator
affiliation: Vanderbilt University
last name: Rene H. Gifford, PhD
role: Study Chair
affiliation: Vanderbilt University Medical Center
last name: Robert F. Labadie, MD, PhD
role: Study Chair
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Jack Noble
investigator title: Research Assistant Professor, Electrical Engineering and Computer Science
sharing ipd: No