<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/NCT03306108</url>
  </required_header>
  <id_info>
    <org_study_id>NRT in Cochlear implantation</org_study_id>
    <nct_id>NCT03306108</nct_id>
  </id_info>
  <brief_title>Correlation Between NRT and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea.</brief_title>
  <official_title>Correlation Between the Neural Response Telemetry (NRT) and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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 study will be conducted as Prospective study including 50 patients (aged &lt;6years ) at&#xD;
      Otorhinolaryngology department, Assuit University Hospital (aged &lt;6years ) who will undergo&#xD;
      cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or&#xD;
      standard electrodes with a standard surgical procedure. The standard surgical procedure will&#xD;
      include extended end aural approach ,posterior tympanotomy and a round window insertion.The&#xD;
      results of immediate postoperative Neural Response Telemetry (NRT) measurements &amp;&#xD;
      postoperative CT imaging will be obtained.&#xD;
&#xD;
      Each patient will be subjected to the following scheme:&#xD;
&#xD;
        -  immediate postoperative Neural Response Telemetry (NRT) measurements&#xD;
&#xD;
        -  postoperative CT imaging&#xD;
&#xD;
        -  Data obtained from both measurements will be used to determine the intra cochlear&#xD;
           electrode position then both data will be correlated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cochlear implantation (CI) is a worldwide accepted and effective surgical procedure for&#xD;
      patients with profound sensory neural hearing loss to gain near normal hearing.1 The position&#xD;
      of electrode inside the cochlea affects the outcomes. Full insertion of the CI electrode&#xD;
      array and insertion in scala tympani usually has optimal results and better words&#xD;
      recognition.2 Translocation of electrode array from scala tympani to scala vestibule or&#xD;
      outword migration of electrode array may result in poor response.2 There are many&#xD;
      intraoperative and post operative techniques to determine the position of electrode array&#xD;
      inside the cochlea, some are radiological as transorbital view plan x-ray or computed&#xD;
      tomography or 3D rotational x ray and others are electrophysiological measurements.3 Although&#xD;
      the accuracy of the radiological techinques they are time and cost consuming1. The&#xD;
      electrically evoked cochlear action potential (ECAP) threshold is dependent on the distance&#xD;
      between the electrodes and the spiral ganglion cells. The neural response telemetry-ratio&#xD;
      (NRT-ratio) is one of the electrophysiological measurments techniques and it is based on each&#xD;
      individual electrode's ECAP threshold and can identify the intracochlear electrode array&#xD;
      position 4. According to a study done by Philipp Mittmann in 2015, a NRT-ratio above 1.05&#xD;
      indicates an electrode translocation from scala tympani to scala vestibuli and a NRT-ratio&#xD;
      below 1.05 shows correlation to a pure scala tympani placement5, but another study found&#xD;
      variation of the NRT-ratio in a group of patients with an electrode placement within scala&#xD;
      tympani.6&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 30, 2017</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Value of Neural Response Telemetry (NRT) &amp; Radiological measurments in evaluation of cochlear implant electrode positions</measure>
    <time_frame>Baseline</time_frame>
    <description>The study will be conducted as Prospective study including 50 patients (aged &lt;6years ) at Otorhinolaryngology department, Assuit University Hospital (aged &lt;6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements &amp; postoperative CT imaging will be obtained.&#xD;
Each patient will be subjected to the following scheme:&#xD;
immediate postoperative Neural Response Telemetry (NRT) measurements&#xD;
postoperative CT imaging&#xD;
Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cochlear Function Disorder</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NRT</intervention_name>
    <description>NRTratio is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position in perimodiolar electrodes. The NRT-ratio showed a good reliability for the determination of the intracochlear electrode array position compared to the radiologic control intraoperatively Calculation of the NRT-ratio is done by dividing the arithmetic average of the t-NRT values from the apical electrodes 16 to 18 divided by the arithmetic average of the basal t-NRT from electrodes 5 to 7. With a NRT-ratio above 1.05, a high chance of a scalar change was rather likely, and a NRT-ratio below 1.05 was associated with a high chance of an electrode array position within the scala tympani.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted as Prospective study at Otorhinolaryngology department, Assuit&#xD;
        University Hospital .. All subjects will undergo implantation with Medel sonata flex 28 or&#xD;
        standard electrodes with a standard surgical procedure. which will include extended end&#xD;
        aural approach ,posterior tympanotomy and a round window insertion.The results of immediate&#xD;
        postoperative NRT measurements &amp; postoperative CT imaging will be obtained.&#xD;
&#xD;
        Each patient will be subjected to the following scheme:&#xD;
&#xD;
          -  immediate postoperative NRT measurements&#xD;
&#xD;
          -  postoperative CT imaging&#xD;
&#xD;
          -  Data obtained from both measurements will be used to determine the intra cochlear&#xD;
             electrode position then both data will be correlated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged &lt; 6years who will undergo cochlear implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision cochlear implantation.&#xD;
&#xD;
          -  incomplete post-operative electrophysiological measurements.&#xD;
&#xD;
          -  unfit patients for surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed Abd El - Aziz, Prof</last_name>
    <role>Study Director</role>
  </overall_official>
  <overall_contact>
    <last_name>Samah Hamdy, residant</last_name>
    <phone>01067989166</phone>
    <email>Samahhamdy92@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Muhammad Modather, Dr</last_name>
    <phone>01061577266</phone>
    <email>MuhammadModather@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>Assiut University71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Lang S, Arweiler-Harbeck D, Christov F. Radiological and NRT-Ratio-Based Estimation of Slim Straight Cochlear Implant Electrode Positions: A Multicenter Study. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):73-78. doi: 10.1177/0003489416675355. Epub 2016 Oct 25.</citation>
    <PMID>27780910</PMID>
  </reference>
  <reference>
    <citation>Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Ramalingam R, Lang S, Christov F, Arweiler-Harbeck D. Electrophysiological detection of scalar changing perimodiolar cochlear electrode arrays: a long term follow-up study. Eur Arch Otorhinolaryngol. 2016 Dec;273(12):4251-4256. doi: 10.1007/s00405-016-4175-2. Epub 2016 Jun 28.</citation>
    <PMID>27351885</PMID>
  </reference>
  <reference>
    <citation>Lathuilliere M, Merklen F, Piron JP, Sicard M, Villemus F, Menjot de Champfleur N, Venail F, Uziel A, Mondain M. Cone-beam computed tomography in children with cochlear implants: The effect of electrode array position on ECAP. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:27-31. doi: 10.1016/j.ijporl.2016.10.033. Epub 2016 Oct 31.</citation>
    <PMID>28012529</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>samah hamdy saeed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03306108
org study id: NRT in Cochlear implantation
nct id: NCT03306108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will be conducted as Prospective study including 50 patients (aged <6years ) at
      Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo
      cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or
      standard electrodes with a standard surgical procedure. The standard surgical procedure will
      include extended end aural approach ,posterior tympanotomy and a round window insertion.The
      results of immediate postoperative Neural Response Telemetry (NRT) measurements &
      postoperative CT imaging will be obtained.

      Each patient will be subjected to the following scheme:

        -  immediate postoperative Neural Response Telemetry (NRT) measurements

        -  postoperative CT imaging

        -  Data obtained from both measurements will be used to determine the intra cochlear
           electrode position then both data will be correlated.
Cochlear implantation (CI) is a worldwide accepted and effective surgical procedure for
      patients with profound sensory neural hearing loss to gain near normal hearing.1 The position
      of electrode inside the cochlea affects the outcomes. Full insertion of the CI electrode
      array and insertion in scala tympani usually has optimal results and better words
      recognition.2 Translocation of electrode array from scala tympani to scala vestibule or
      outword migration of electrode array may result in poor response.2 There are many
      intraoperative and post operative techniques to determine the position of electrode array
      inside the cochlea, some are radiological as transorbital view plan x-ray or computed
      tomography or 3D rotational x ray and others are electrophysiological measurements.3 Although
      the accuracy of the radiological techinques they are time and cost consuming1. The
      electrically evoked cochlear action potential (ECAP) threshold is dependent on the distance
      between the electrodes and the spiral ganglion cells. The neural response telemetry-ratio
      (NRT-ratio) is one of the electrophysiological measurments techniques and it is based on each
      individual electrode's ECAP threshold and can identify the intracochlear electrode array
      position 4. According to a study done by Philipp Mittmann in 2015, a NRT-ratio above 1.05
      indicates an electrode translocation from scala tympani to scala vestibuli and a NRT-ratio
      below 1.05 shows correlation to a pure scala tympani placement5, but another study found
      variation of the NRT-ratio in a group of patients with an electrode placement within scala
      tympani.6
observational model: Cohort
time perspective: Prospective
measure: Value of Neural Response Telemetry (NRT) & Radiological measurments in evaluation of cochlear implant electrode positions
time frame: Baseline
description: The study will be conducted as Prospective study including 50 patients (aged <6years ) at Otorhinolaryngology department, Assuit University Hospital (aged <6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements & postoperative CT imaging will be obtained.
Each patient will be subjected to the following scheme:
immediate postoperative Neural Response Telemetry (NRT) measurements
postoperative CT imaging
Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.
intervention type: Device
intervention name: NRT
description: NRTratio is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position in perimodiolar electrodes. The NRT-ratio showed a good reliability for the determination of the intracochlear electrode array position compared to the radiologic control intraoperatively Calculation of the NRT-ratio is done by dividing the arithmetic average of the t-NRT values from the apical electrodes 16 to 18 divided by the arithmetic average of the basal t-NRT from electrodes 5 to 7. With a NRT-ratio above 1.05, a high chance of a scalar change was rather likely, and a NRT-ratio below 1.05 was associated with a high chance of an electrode array position within the scala tympani.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohammed Abd El - Aziz, Prof
role: Study Director
last name: Samah Hamdy, residant
phone: 01067989166
email: Samahhamdy92@gmail.com
last name: Muhammad Modather, Dr
phone: 01061577266
email: MuhammadModather@yahoo.com
facility: 
country: Egypt
citation: Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Lang S, Arweiler-Harbeck D, Christov F. Radiological and NRT-Ratio-Based Estimation of Slim Straight Cochlear Implant Electrode Positions: A Multicenter Study. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):73-78. doi: 10.1177/0003489416675355. Epub 2016 Oct 25.
PMID: 27780910
citation: Mittmann P, Todt I, Ernst A, Rademacher G, Mutze S, Goricke S, Schlamann M, Ramalingam R, Lang S, Christov F, Arweiler-Harbeck D. Electrophysiological detection of scalar changing perimodiolar cochlear electrode arrays: a long term follow-up study. Eur Arch Otorhinolaryngol. 2016 Dec;273(12):4251-4256. doi: 10.1007/s00405-016-4175-2. Epub 2016 Jun 28.
PMID: 27351885
citation: Lathuilliere M, Merklen F, Piron JP, Sicard M, Villemus F, Menjot de Champfleur N, Venail F, Uziel A, Mondain M. Cone-beam computed tomography in children with cochlear implants: The effect of electrode array position on ECAP. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:27-31. doi: 10.1016/j.ijporl.2016.10.033. Epub 2016 Oct 31.
PMID: 28012529
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: samah hamdy saeed
investigator title: principal investigator