<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/NCT03300193</url>
  </required_header>
  <id_info>
    <org_study_id>0162-15-RMB</org_study_id>
    <nct_id>NCT03300193</nct_id>
  </id_info>
  <brief_title>The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease</brief_title>
  <acronym>MRgFUS</acronym>
  <official_title>The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will investigate Essential Tremor and Parkinson's Disease patients who underwent&#xD;
      Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of&#xD;
      lesion characteristics on tremor and on quality of life after the procedure as compared with&#xD;
      the baseline prior to the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to investigate the effect of lesion characteristics in ExAblate&#xD;
      Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim&#xD;
      thalamic nucleus. Clinical measures will be used to study patients suffering from&#xD;
      medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.&#xD;
&#xD;
      This study is designed as a prospective, observational, and clinical study. Assessments will&#xD;
      be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL)&#xD;
      improvements, assessment of adverse events, and correlations of these measures with the size&#xD;
      and shape of the lesion and the surrounding edema .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Clinical Rating Scale for Tremor</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor part of Unified PD Rating Scale</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>In PD patients - Motor part of Unified PD Rating Scale (UPDRS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Essential Tremor Questionnaire</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parkinson's Disease Questionnaire</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>Parkinson's Disease Questionnaire (PDQ39)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iSeismometer application</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>adverse events of the MRgFUS</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>Assessment of adverse events of the MRgFUS</description>
  </other_outcome>
  <other_outcome>
    <measure>assessment of the location of lesion on MRI</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>assessment of the location of the lesion in post procedure MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Size of the lesion on MRI</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>volume in mm3 of lesion in post procedure MRI</description>
  </other_outcome>
  <other_outcome>
    <measure>Surrounding edema on MRI</measure>
    <time_frame>3 MONTHS</time_frame>
    <description>volume in mm3 of edema in post procedure MRI</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Tremor</condition>
  <arm_group>
    <arm_group_label>Tremor patients</arm_group_label>
    <description>Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor&#xD;
        that underwent MRgFUS procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, between 18 and 80 years.&#xD;
&#xD;
          -  Patients who underwent the MRgFUS procedure.&#xD;
&#xD;
          -  Patients who are able and willing to give consent and able to attend all study visits&#xD;
             and Radiologic follow-up examination by MRI.&#xD;
&#xD;
          -  A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination&#xD;
             preformed by a movement disorders neurologist.&#xD;
&#xD;
          -  ET patients: tremor severity score of greater than or equal to 2 in the treated&#xD;
             hand/arm as measured by postural or action item on the Clinical Rating Scale for&#xD;
             Tremor (CRST).&#xD;
&#xD;
          -  PD patients: tremor severity score of equal or greater than 3 on either item 20 or&#xD;
             item 21 of motor part in the Unified PD Rating Scale (UPDRS).&#xD;
&#xD;
          -  Substantial disability in the performance of at least two daily activities from the&#xD;
             disability subsection of the scales UPDRS for PD patients or CRST for ET patients.&#xD;
&#xD;
          -  The patient must have a history of an unsatisfactory response to medical management.&#xD;
             All patients will need to have tried and failed at least one drug. Alternatively, a&#xD;
             patient may also qualify if tremor-suppressing medications are contraindicated due to&#xD;
             a coexisting medical condition or drug allergy.&#xD;
&#xD;
          -  Stable doses of all medications for 30 days prior to study entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients which have not completed the MRgFUS procedure.&#xD;
&#xD;
          -  Patients which were diagnosed during the trial with additional diagnoses that can&#xD;
             affect motor function, quality of life and symptoms of tremor.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Menashe Zaaroor, MD, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 29, 2016</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Menashe Zaaroor, MD PhD</investigator_full_name>
    <investigator_title>Head of Neurosurgical Department</investigator_title>
  </responsible_party>
  <keyword>Magnetic Resonance guided Focused Ultrasound</keyword>
  <keyword>Tremor</keyword>
  <keyword>Essential Tremor</keyword>
  <keyword>Parkinson's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Essential Tremor</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD</ipd_description>
  </patient_data>
  <!-- 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/NCT03300193
org study id: 0162-15-RMB
nct id: NCT03300193
lead sponsor: 
has dmc: No
The study will investigate Essential Tremor and Parkinson's Disease patients who underwent
      Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of
      lesion characteristics on tremor and on quality of life after the procedure as compared with
      the baseline prior to the procedure.
The purpose of the study is to investigate the effect of lesion characteristics in ExAblate
      Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim
      thalamic nucleus. Clinical measures will be used to study patients suffering from
      medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease.

      This study is designed as a prospective, observational, and clinical study. Assessments will
      be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL)
      improvements, assessment of adverse events, and correlations of these measures with the size
      and shape of the lesion and the surrounding edema .
observational model: Cohort
time perspective: Prospective
measure: Clinical Rating Scale for Tremor
time frame: 3 MONTHS
description: Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)
measure: Motor part of Unified PD Rating Scale
time frame: 3 MONTHS
description: In PD patients - Motor part of Unified PD Rating Scale (UPDRS)
measure: Quality of Life Essential Tremor Questionnaire
time frame: 3 MONTHS
description: Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)
measure: Parkinson's Disease Questionnaire
time frame: 3 MONTHS
description: Parkinson's Disease Questionnaire (PDQ39)
measure: iSeismometer application
time frame: 3 MONTHS
description: For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.
measure: adverse events of the MRgFUS
time frame: 3 MONTHS
description: Assessment of adverse events of the MRgFUS
measure: assessment of the location of lesion on MRI
time frame: 3 MONTHS
description: assessment of the location of the lesion in post procedure MRI
measure: Size of the lesion on MRI
time frame: 3 MONTHS
description: volume in mm3 of lesion in post procedure MRI
measure: Surrounding edema on MRI
time frame: 3 MONTHS
description: volume in mm3 of edema in post procedure MRI
arm group label: Tremor patients
description: Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Menashe Zaaroor, MD, DSc
role: Principal Investigator
affiliation: Rambam Health Care Campus
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Menashe Zaaroor, MD PhD
investigator title: Head of Neurosurgical Department
mesh term: Parkinson Disease
mesh term: Tremor
mesh term: Essential Tremor
sharing ipd: Yes
ipd description: IPD