<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/NCT02246231</url>
  </required_header>
  <id_info>
    <org_study_id>R01623</org_study_id>
    <nct_id>NCT02246231</nct_id>
  </id_info>
  <brief_title>Effect of Implant Position on Magnetic Resonance Image Distortion</brief_title>
  <official_title>The Effect of Changes in Head Position on Magnetic Resonance Image Distortion in Patients With Auditory Implants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester University NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both&#xD;
      ears. As a result of the tumours themselves or the treatment of the tumours, many patients&#xD;
      become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing&#xD;
      a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is&#xD;
      termed an auditory brainstem implant (ABI).&#xD;
&#xD;
      The aim of this study is to find the optimum head position in relation to the MRI magnet&#xD;
      field, which would produce least area of image distortion in patients with ABIs. This will be&#xD;
      of benefit in optimising the MR imaging in future patients with implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Auditory brainstem implants (ABI) are placed against the auditory centres in the brainstem if&#xD;
      it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural&#xD;
      signals from the cochlea to the brainstem, is damaged or absent. The latter device is usually&#xD;
      used in patients with Neurofibromatosis type 2 (NF2) who develop bilateral benign inner ear&#xD;
      tumours called vestibular schwannomas as well as other neurological tumours1. These patients&#xD;
      often become bilaterally profoundly deaf either as a result of the disease or because of&#xD;
      surgery to remove the tumours and require an ABI.&#xD;
&#xD;
      Patients with NF2 require monitoring of their tumours. In the absence of an auditory implant&#xD;
      it is possible to use magnetic resonance imaging. This is the gold standard imaging technique&#xD;
      as it gives excellent views of the soft tissues of head. However, there has been concern&#xD;
      regarding the use of MRI in patients with auditory implants until recently because of&#xD;
      potential problems such as demagnetisation of the magnet within the implant, implant magnet&#xD;
      displacement and risk to the integrity of the implant electronics. In addition, the magnet&#xD;
      field of the implant magnet results in imaging artefact (manifesting as a signal void) around&#xD;
      the implant site that limits the information that can be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2014</start_date>
  <completion_date type="Actual">January 31, 2015</completion_date>
  <primary_completion_date type="Actual">January 31, 2015</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To identify if there is an angle at which the signal void is minimised</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Neurofibromatosis Type 2</condition>
  <arm_group>
    <arm_group_label>NF2 who has an auditory implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR imaging</intervention_name>
    <arm_group_label>NF2 who has an auditory implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Any patient over the age of 18 with NF2 who has an auditory implant (cochlear or auditory&#xD;
        brainstem implant) in situ and requires MRI scanning.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children under the age of 18 years Claustrophobia Bilateral implants&#xD;
&#xD;
        Contraindications and relative contraindications for MRI (as per the Radiology Department&#xD;
        MRI protocol) including:&#xD;
&#xD;
        Pacemaker Certain metallic heart valves Ferromagnetic implanted materials and foreign&#xD;
        bodies&#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>Simon Lloyd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>Manchester (Manchester Borough)</state>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurofibromatoses</mesh_term>
    <mesh_term>Neurofibromatosis 1</mesh_term>
    <mesh_term>Neurofibroma</mesh_term>
    <mesh_term>Neurofibromatosis 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02246231
org study id: R01623
nct id: NCT02246231
lead sponsor: 
has dmc: Yes
Patients with Neurofibromatosis type 2 (NF2) almost always develop acoustic neuromas in both
      ears. As a result of the tumours themselves or the treatment of the tumours, many patients
      become profoundly deaf in both ears. It is possible to restore a degree of hearing by placing
      a hearing implant in the brainstem adjacent to the hearing pathways within the brain. This is
      termed an auditory brainstem implant (ABI).

      The aim of this study is to find the optimum head position in relation to the MRI magnet
      field, which would produce least area of image distortion in patients with ABIs. This will be
      of benefit in optimising the MR imaging in future patients with implants.
Auditory brainstem implants (ABI) are placed against the auditory centres in the brainstem if
      it is not possible to implant the cochlea or if the cochlear nerve, which conveys neural
      signals from the cochlea to the brainstem, is damaged or absent. The latter device is usually
      used in patients with Neurofibromatosis type 2 (NF2) who develop bilateral benign inner ear
      tumours called vestibular schwannomas as well as other neurological tumours1. These patients
      often become bilaterally profoundly deaf either as a result of the disease or because of
      surgery to remove the tumours and require an ABI.

      Patients with NF2 require monitoring of their tumours. In the absence of an auditory implant
      it is possible to use magnetic resonance imaging. This is the gold standard imaging technique
      as it gives excellent views of the soft tissues of head. However, there has been concern
      regarding the use of MRI in patients with auditory implants until recently because of
      potential problems such as demagnetisation of the magnet within the implant, implant magnet
      displacement and risk to the integrity of the implant electronics. In addition, the magnet
      field of the implant magnet results in imaging artefact (manifesting as a signal void) around
      the implant site that limits the information that can be obtained.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: To study the effect of magnet orientation in auditory brainstem implants/ cochlear implants in determining the size of signal void seen on MRI scanning.
time frame: 1 year
measure: To identify if there is an angle at which the signal void is minimised
time frame: 1 year
arm group label: NF2 who has an auditory implant
arm group type: Experimental
intervention type: Device
intervention name: MR imaging
arm group label: NF2 who has an auditory implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Lloyd
role: Principal Investigator
affiliation: Manchester University NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neurofibromatoses
mesh term: Neurofibromatosis 1
mesh term: Neurofibroma
mesh term: Neurofibromatosis 2