<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/NCT01699477</url>
  </required_header>
  <id_info>
    <org_study_id>E-04/2008</org_study_id>
    <nct_id>NCT01699477</nct_id>
  </id_info>
  <brief_title>Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain</brief_title>
  <acronym>FUS-CLT</acronym>
  <official_title>MR-Guided Functional Ultrasound-Neurosurgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Children's Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to asses the efficacy and the clinical safety of the transcranial&#xD;
      magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec&#xD;
      Ltd. for functional neurosurgery. The treatments to be conducted in this study are&#xD;
      non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific&#xD;
      target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will&#xD;
      be used to evaluate the basic safety aspects of this new treatment technology and will serve&#xD;
      as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2008</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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>Precision of lesioning</measure>
    <time_frame>3 months</time_frame>
    <description>Comparison of size and location of sonicaion lesions on MRI with planning coordinates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety measurements</measure>
    <time_frame>6 months</time_frame>
    <description>Number of Participants with Adverse Events as a Measure of Safety and Tolerability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lesion characteristics</measure>
    <time_frame>3 months</time_frame>
    <description>Size of lesions as a function of applied energy/temperature.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Efficacy</measure>
    <time_frame>1 year</time_frame>
    <description>Pain Scores on the Visual Analog Scale following intervention and at follow-up.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Functional Brain Disorders /Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>Trancranial MRg Focused Ultrasound for Neuropatic Pain</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ExAblate 4000 focused ultrasound brain intervention</intervention_name>
    <description>Non-invasive brain intervention using MR-guided focused ultrasound</description>
    <arm_group_label>Trancranial MRg Focused Ultrasound for Neuropatic Pain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients 18 years and older&#xD;
&#xD;
          2. Clinical indication for a medial thalamotomy&#xD;
&#xD;
          3. Stereotactic targets within thalamus, subthalamus and pallidum&#xD;
&#xD;
          4. All targets supposedly accessible by TcMRgFUS&#xD;
&#xD;
          5. Physically and mentally able to understand the risks of participating in this study&#xD;
             and to give written informed consent based on the patient information provided&#xD;
&#xD;
          6. Sufficient proficiency in one of the languages German, French, Italian or English to&#xD;
             al-low for verbal communication during all phases of the study&#xD;
&#xD;
          7. Physically and mentally able to communicate the personal condition and all feelings&#xD;
             during the TcMRgFUS treatment&#xD;
&#xD;
          8. Physically and mentally able to undergo the TcMRgFUS treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anomalies of brain anatomy, especially in or around thalamus or pallidum that will&#xD;
             in-fluence the atlas-based navigation&#xD;
&#xD;
          2. Existing lesions in close proximity (&lt;5mm) to planned ablation targets&#xD;
&#xD;
          3. Extended anomalies of scalp such as scars, inflammations, etc.&#xD;
&#xD;
          4. Clips or other implanted objects close to (&lt; 3cm) target&#xD;
&#xD;
          5. Non-MRI-compatible cardiac pacemaker&#xD;
&#xD;
          6. Previous hemorrhages in the brain&#xD;
&#xD;
          7. Uncontrolled arterial hypertension&#xD;
&#xD;
          8. Any coagulopathy or patient under anticoagulant therapy&#xD;
&#xD;
          9. Sensitivity to MRI contrast agents&#xD;
&#xD;
         10. Contraindications to MRI such as non-MRI-compatible implanted devices&#xD;
&#xD;
         11. Large patients not fitting comfortably into the MRI unit (generally &gt;110kg)&#xD;
&#xD;
         12. Difficulty to lie supine and still for up to 4 hours in the MRI unit or claustrophobia&#xD;
&#xD;
         13. Other known life-threatening systemic disease&#xD;
&#xD;
         14. Patients currently participating or participated in another clinical trial in the last&#xD;
             30 days&#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>Ernst - Martin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Children's Hospital, Zurich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald - Bauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurosurgery, Kantonsspital St. Gallen, Switzerland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gunther - Landmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Pain Medicine, Nottwil, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ernst - Martin, MD</last_name>
    <phone>+41 44 266 7111</phone>
    <phone_ext>7437</phone_ext>
    <email>ernst.martin@kispi.uzh.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beat - Werner, MSc</last_name>
    <phone>+41 44 266 7111</phone>
    <phone_ext>8123</phone_ext>
    <email>beat.werner@kispi.uzh.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>MR-Center, University Children's Hospital</name>
      <address>
        <city>Zurich</city>
        <zip>CH-8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ernst - Martin, MD</last_name>
      <phone>+41 44 266 7111</phone>
      <phone_ext>7437</phone_ext>
      <email>ernst.martin@kispi.uzh.ch</email>
    </contact>
    <contact_backup>
      <last_name>Ronald - Bauer, MD</last_name>
      <phone>+41 71 494 1111</phone>
      <phone_ext>3054</phone_ext>
      <email>ronald.bauer@kssg.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Ernst - Martin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Beat - Werner, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>April 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>FUS</keyword>
  <keyword>focused ultrasound</keyword>
  <keyword>functional brain disorders</keyword>
  <keyword>neuropathic pain</keyword>
  <keyword>movement disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
    <mesh_term>Brain Diseases</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 12, 2013</submitted>
    <returned>November 14, 2013</returned>
    <submitted>October 7, 2014</submitted>
    <returned>October 9, 2014</returned>
    <submitted>January 22, 2015</submitted>
    <returned>February 6, 2015</returned>
    <submitted>March 16, 2015</submitted>
    <returned>March 21, 2015</returned>
    <submitted>August 24, 2015</submitted>
    <returned>September 23, 2015</returned>
    <submitted>June 3, 2016</submitted>
    <returned>July 13, 2016</returned>
    <submitted>October 28, 2016</submitted>
    <returned>December 20, 2016</returned>
  </pending_results>
  <!-- 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/NCT01699477
org study id: E-04/2008
nct id: NCT01699477
lead sponsor: 
has dmc: Yes
The aim of this study is to asses the efficacy and the clinical safety of the transcranial
      magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec
      Ltd. for functional neurosurgery. The treatments to be conducted in this study are
      non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific
      target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will
      be used to evaluate the basic safety aspects of this new treatment technology and will serve
      as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Precision of lesioning
time frame: 3 months
description: Comparison of size and location of sonicaion lesions on MRI with planning coordinates.
measure: Safety measurements
time frame: 6 months
description: Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
measure: Lesion characteristics
time frame: 3 months
description: Size of lesions as a function of applied energy/temperature.
measure: Clinical Efficacy
time frame: 1 year
description: Pain Scores on the Visual Analog Scale following intervention and at follow-up.
arm group label: Trancranial MRg Focused Ultrasound for Neuropatic Pain
arm group type: Other
intervention type: Device
intervention name: ExAblate 4000 focused ultrasound brain intervention
description: Non-invasive brain intervention using MR-guided focused ultrasound
arm group label: Trancranial MRg Focused Ultrasound for Neuropatic Pain
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ernst - Martin, MD
role: Principal Investigator
affiliation: University Children's Hospital, Zurich
last name: Ronald - Bauer, MD
role: Principal Investigator
affiliation: Neurosurgery, Kantonsspital St. Gallen, Switzerland
last name: Gunther - Landmann, MD
role: Principal Investigator
affiliation: Center for Pain Medicine, Nottwil, Switzerland
last name: Ernst - Martin, MD
phone: +41 44 266 7111
phone ext: 7437
email: ernst.martin@kispi.uzh.ch
last name: Beat - Werner, MSc
phone: +41 44 266 7111
phone ext: 8123
email: beat.werner@kispi.uzh.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Brain Diseases
submitted: September 12, 2013
returned: November 14, 2013
submitted: October 7, 2014
returned: October 9, 2014
submitted: January 22, 2015
returned: February 6, 2015
submitted: March 16, 2015
returned: March 21, 2015
submitted: August 24, 2015
returned: September 23, 2015
submitted: June 3, 2016
returned: July 13, 2016
submitted: October 28, 2016
returned: December 20, 2016