<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/NCT02252380</url>
  </required_header>
  <id_info>
    <org_study_id>MD003</org_study_id>
    <nct_id>NCT02252380</nct_id>
  </id_info>
  <brief_title>ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders</brief_title>
  <official_title>A Feasibility Clinical Trial of the Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for the Management of Treatment-Refractory Movement Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InSightec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InSightec</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool&#xD;
      for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients&#xD;
      with treatment-refractory symptoms of movement disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided&#xD;
      focused ultrasound thermal ablation of a designated area in the brain of patients suffering&#xD;
      from movement disorder symptoms:&#xD;
&#xD;
        -  FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients&#xD;
           suffering from treatment-refractory movement disorders through an intact human skull&#xD;
           with a low risk of transient adverse effects as evaluated during follow-up of up to&#xD;
           12-months.&#xD;
&#xD;
        -  A pre-defined target volume inside the brain can be accurately ablated, as demonstrated&#xD;
           on post-treatment MRI.&#xD;
&#xD;
        -  Lesions generated with ExAblate Neuro will result in clinical effects that are similar&#xD;
           to those seen with ablative procedures using other surgical techniques (e.g. RF&#xD;
           procedure).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of Device and Procedure Related Complications</measure>
    <time_frame>At the time of ExAblate procedure</time_frame>
    <description>Safety will be evaluated individually for each subject who is treated</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Movement Disorders</condition>
  <condition>Essential Tremor</condition>
  <condition>Holmes Tremor</condition>
  <condition>Parkinson's Disease</condition>
  <condition>Wilson's Disease</condition>
  <condition>Huntington's Disease</condition>
  <condition>Dystonia</condition>
  <condition>Tardive Dyskinesia</condition>
  <condition>Orofacial Dyskinesias</condition>
  <arm_group>
    <arm_group_label>Transcranial ExAblate System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial ExAblate System (MRgFUS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial ExAblate System</intervention_name>
    <description>MR Guided Focused Ultrasound</description>
    <arm_group_label>Transcranial ExAblate System</arm_group_label>
    <other_name>MRgFUS</other_name>
    <other_name>Focused Ultrasound</other_name>
    <other_name>FUS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, between 18 and 85 years, inclusive.&#xD;
&#xD;
          -  Subjects who are able and willing to give consent and able to attend all study visits.&#xD;
&#xD;
          -  A movement disorder symptom that has been deemed treatment-refractory by a movement&#xD;
             disorder neurologist, including:&#xD;
&#xD;
             o akathisia, akinesia, athetosis, bradykinesia, chorea, dystonia, tremor, myoclonus,&#xD;
             dyskinesia, spasms, tics&#xD;
&#xD;
          -  Medication-refractoriness as determined by an adequate dose and duration of standard&#xD;
             movement disorders treatment as determined by a specialist neurologist (e.g. a trial&#xD;
             of primidone and propranolol for ET)&#xD;
&#xD;
          -  Able to communicate sensations during the ExAblate Neuro treatment&#xD;
&#xD;
          -  Stable doses of all medications for 30 days prior to study entry and for the duration&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with unstable cardiac status including:&#xD;
&#xD;
               -  Unstable angina pectoris on medication&#xD;
&#xD;
               -  Patients with documented myocardial infarction within six months of protocol&#xD;
                  entry&#xD;
&#xD;
               -  Congestive heart failure requiring medication (other than diuretic)&#xD;
&#xD;
               -  Patients on anti-arrhythmic drugs&#xD;
&#xD;
          -  Severe hypertension (diastolic BP &gt; 100 on medication)&#xD;
&#xD;
          -  Patients with standard contraindications for MR imaging such as non-MRI compatible&#xD;
             implanted metallic devices including cardiac pacemakers, size limitations, etc.&#xD;
&#xD;
          -  History of abnormal bleeding and/or coagulopathy (including deep venous thrombosis)&#xD;
&#xD;
          -  Cerebrovascular disease (multiple CVA or CVA within 6 months)&#xD;
&#xD;
          -  Symptoms and signs of increased intracranial pressure (e.g. headache, nausea,&#xD;
             vomiting, lethargy, and papilledema)&#xD;
&#xD;
          -  Untreated, uncontrolled sleep apnea&#xD;
&#xD;
          -  Active or suspected acute or chronic uncontrolled infection&#xD;
&#xD;
          -  History of intracranial hemorrhage&#xD;
&#xD;
          -  Individuals who are not able or willing to tolerate the required prolonged stationary&#xD;
             supine position during treatment&#xD;
&#xD;
          -  Are participating or have participated in another clinical trial in the last 30 days&#xD;
&#xD;
          -  Patients unable to communicate with the investigator and staff.&#xD;
&#xD;
          -  Presence of any other neurodegenerative disease like multisystem atrophy, progressive&#xD;
             supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.&#xD;
&#xD;
          -  Patients with a history of seizures within the past year&#xD;
&#xD;
          -  Patients with psychiatric illness that are not well controlled. Any presence of&#xD;
             psychosis will be excluded.&#xD;
&#xD;
          -  Patients with risk factors for intraoperative or postoperative bleeding (platelet&#xD;
             count less than 100,000 per cubic millimeter) or a documented coagulopathy&#xD;
&#xD;
          -  Patients with brain tumors&#xD;
&#xD;
          -  Any illness that in the investigator's opinion preclude participation in this study.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Patient is unable to provide his own consent for any reason.&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity.&#xD;
&#xD;
          -  Patients who have DBS or a prior stereotactic ablation of the basal ganglia&#xD;
&#xD;
          -  History of immunocompromise, including patient who is HIV positive&#xD;
&#xD;
          -  Known life-threatening systemic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres Lozano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Western Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</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>Hepatolenticular Degeneration</mesh_term>
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
    <mesh_term>Huntington Disease</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
    <mesh_term>Essential Tremor</mesh_term>
    <mesh_term>Tardive Dyskinesia</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/NCT02252380
org study id: MD003
nct id: NCT02252380
lead sponsor: 
has dmc: Yes
The proposed study is to evaluate the effectiveness of ExAblate Transcranial MRgFUS as a tool
      for creating a unilateral lesion in the Vim thalamus or the globus pallidus (GPi) in patients
      with treatment-refractory symptoms of movement disorders.
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided
      focused ultrasound thermal ablation of a designated area in the brain of patients suffering
      from movement disorder symptoms:

        -  FUS under MRI-guidance and MRI-based thermometry can be safely delivered to patients
           suffering from treatment-refractory movement disorders through an intact human skull
           with a low risk of transient adverse effects as evaluated during follow-up of up to
           12-months.

        -  A pre-defined target volume inside the brain can be accurately ablated, as demonstrated
           on post-treatment MRI.

        -  Lesions generated with ExAblate Neuro will result in clinical effects that are similar
           to those seen with ablative procedures using other surgical techniques (e.g. RF
           procedure).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Severity of Device and Procedure Related Complications
time frame: At the time of ExAblate procedure
description: Safety will be evaluated individually for each subject who is treated
arm group label: Transcranial ExAblate System
arm group type: Experimental
description: Transcranial ExAblate System (MRgFUS)
intervention type: Device
intervention name: Transcranial ExAblate System
description: MR Guided Focused Ultrasound
arm group label: Transcranial ExAblate System
other name: MRgFUS
other name: Focused Ultrasound
other name: FUS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Andres Lozano, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hepatolenticular Degeneration
mesh term: Parkinson Disease
mesh term: Dystonia
mesh term: Tremor
mesh term: Dyskinesias
mesh term: Huntington Disease
mesh term: Movement Disorders
mesh term: Essential Tremor
mesh term: Tardive Dyskinesia