xml: <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/NCT06013215</url>
    </required_header>
    <id_info>
      <org_study_id>DR230050-PULSE</org_study_id>
      <secondary_id>2023-A00476-39</secondary_id>
      <secondary_id>DR230050</secondary_id>
      <nct_id>NCT06013215</nct_id>
    </id_info>
    <brief_title>Electrical Impulse Parameters and Neuronal Population in the Cochlear Implanted Patient-PULSE</brief_title>
    <acronym>PULSE</acronym>
    <official_title>PULSE - Paramètres de l'Impulsion électrique et Population Neuronale Chez le Patient implanté cochléaire - Etude en Ouvert, Non contrôlé, Non randomisée</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Tours</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Tours</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 cochlear implant provides good auditory performance despite high inter-individual&#xD;
        variability, but performance in noise remains limited. Modification of the coding strategies&#xD;
        could improve these performances. A better characterization of the remaining neuronal&#xD;
        population by looking for the charge integration efficiency (which depends on the duration&#xD;
        and the amplitude of the electrical pulse) would allow an optimization of the settings by&#xD;
        adapting either the duration or the amplitude of the pulse according to the quality of the&#xD;
        remaining neuronal population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The cochlear implant provides good auditory performance despite high inter-individual&#xD;
        variability, but performance in noise remains limited. Modification of the coding strategies&#xD;
        could improve these performances. Currently, the intensity perceived by the patient is coded&#xD;
        by the duration and the amplitude of the electrical impulse but companies have different&#xD;
        approaches and fix one of the two parameters for the setting of the processors. A better&#xD;
        characterization of the remaining neuronal population by looking for the charge integration&#xD;
        efficiency (which depends on the duration and the amplitude of the electrical pulse) would&#xD;
        allow an optimization of the settings by adapting either the duration or the amplitude of the&#xD;
        pulse according to the quality of the remaining neuronal population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 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>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Calculate the charge integration efficiency along the electrodes</measure>
      <time_frame>4 hours</time_frame>
      <description>Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Questionnaire between Intensity discrimination and charge integration efficiency</measure>
      <time_frame>4 hours</time_frame>
      <description>3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Sensorineural Hearing Loss</condition>
    <arm_group>
      <arm_group_label>Cochlear implant users with Neuro Zti array</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cochlear implant (Oticon) stimulation parameter optimization</intervention_name>
      <description>The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception</description>
      <arm_group_label>Cochlear implant users with Neuro Zti array</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  post-lingually deaf adults with at least one year of cochlear implant experience&#xD;
  &#xD;
            -  unilateral and bilateral cochlear implant recipients&#xD;
  &#xD;
            -  Oticon device with Neuro Zti array&#xD;
  &#xD;
            -  Patient affiliated to french social security&#xD;
  &#xD;
            -  Consent signed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under court protection, guardianship or curatorship&#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>David Bakhos</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Tours</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David Bakhos, MD, PhD</last_name>
      <phone>+33 (0)218370523</phone>
      <email>bakhos.david@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elodie MOUSSET, MSc</last_name>
      <phone>+33 (0)247474665</phone>
      <email>E.MOUSSET@chu-tours.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hearing loss</keyword>
    <keyword>cochlear implant</keyword>
    <keyword>psychoacoustic</keyword>
    <keyword>charge integration efficiency</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hearing Loss</mesh_term>
      <mesh_term>Deafness</mesh_term>
      <mesh_term>Hearing Loss, Sensorineural</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013215
  org study id: DR230050-PULSE
  secondary id: 2023-A00476-39
  secondary id: DR230050
  nct id: NCT06013215
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The cochlear implant provides good auditory performance despite high inter-individual
        variability, but performance in noise remains limited. Modification of the coding strategies
        could improve these performances. A better characterization of the remaining neuronal
        population by looking for the charge integration efficiency (which depends on the duration
        and the amplitude of the electrical pulse) would allow an optimization of the settings by
        adapting either the duration or the amplitude of the pulse according to the quality of the
        remaining neuronal population.
  The cochlear implant provides good auditory performance despite high inter-individual
        variability, but performance in noise remains limited. Modification of the coding strategies
        could improve these performances. Currently, the intensity perceived by the patient is coded
        by the duration and the amplitude of the electrical impulse but companies have different
        approaches and fix one of the two parameters for the setting of the processors. A better
        characterization of the remaining neuronal population by looking for the charge integration
        efficiency (which depends on the duration and the amplitude of the electrical pulse) would
        allow an optimization of the settings by adapting either the duration or the amplitude of the
        pulse according to the quality of the remaining neuronal population.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Calculate the charge integration efficiency along the electrodes
  time frame: 4 hours
  description: Charge integration efficiency will be determined for each electrode by noting the minimum and maximum loudness perceived by the patient as function of pulse phase duration and amplitude
  measure: Questionnaire between Intensity discrimination and charge integration efficiency
  time frame: 4 hours
  description: 3 electrodes that span the range of charge integration efficiency values will be selected as test electrodes. Three intensities will be presented to the patient through the implant and it will be asked to the patient to determine which intensity is higher than the others.
  arm group label: Cochlear implant users with Neuro Zti array
  arm group type: Experimental
  description: Post-lingually cochlear implant users with 12 months of auditory experience Modifications of pulse parameters to determine the charge integration efficiency which is related with neuron survival population
  intervention type: Other
  intervention name: Cochlear implant (Oticon) stimulation parameter optimization
  description: The pulse amplitude and/or the pulse phase duration will be optimize to improve the intensity resolution of the cochlear implant which may benefit speech perception
  arm group label: Cochlear implant users with Neuro Zti array
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Bakhos
  role: Principal Investigator
  affiliation: University Hospital, Tours
  last name: David Bakhos, MD, PhD
  phone: +33 (0)218370523
  email: bakhos.david@gmail.com
  last name: Elodie MOUSSET, MSc
  phone: +33 (0)247474665
  email: E.MOUSSET@chu-tours.fr
  responsible party type: Sponsor
  mesh term: Hearing Loss
  mesh term: Deafness
  mesh term: Hearing Loss, Sensorineural