<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/NCT02255929</url>
  </required_header>
  <id_info>
    <org_study_id>IR 5585</org_study_id>
    <nct_id>NCT02255929</nct_id>
  </id_info>
  <brief_title>Gamma Knife Radiosurgery for Treatment of Essential Tremor</brief_title>
  <official_title>Gamma Knife Thalamotomy for Treatment of Essential Tremor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery&#xD;
      for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is being done because although multiple studies evaluating gamma knife for&#xD;
      essential tremor show good results, few studies evaluating patients prospectively have been&#xD;
      done. Prior studies have looked at patient outcomes following treatment - also known as&#xD;
      retrospective studies. In this study, data collection will initiate before treatment, to&#xD;
      obtain consistent baseline evaluations from all study participants undergoing the gamma knife&#xD;
      treatment and at specific intervals following treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</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>Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.</measure>
    <time_frame>Baseline, 6, 12, 24, and 36 Months Post Treatment</time_frame>
    <description>The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy</measure>
    <time_frame>Baseline, 6, 12, 24, and 36 Months Post Treatment</time_frame>
    <description>Adverse Events to be reported as mild, moderate or severe</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">183</enrollment>
  <condition>Essential Tremor</condition>
  <arm_group>
    <arm_group_label>Gamma Knife Radiosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Gamma Knife Radiosurgery</intervention_name>
    <arm_group_label>Gamma Knife Radiosurgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women age 18 years or older&#xD;
&#xD;
          -  Diagnosis of essential tremor as confirmed from clinical history and examination by a&#xD;
             neurologist or neurosurgeon&#xD;
&#xD;
          -  Tremor following prior first line therapy with either propranolol or primidone&#xD;
&#xD;
          -  Must be able to undergo MRI of brain and CT of head for treatment planning&#xD;
&#xD;
          -  Postural or intention tremor severity score of greater than or equal to 2 in one&#xD;
             hand/arm as measured by the CRST rating scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior ipsilateral stereotactic radiosurgical ablation of the thalamus, ipsilateral&#xD;
             deep brain stimulation, radiofrequency ablation of a ipsilateral thalamic target, or&#xD;
             ultrasound ablation of an ipsilateral thalamic target&#xD;
&#xD;
          -  Prior whole brain radiation therapy&#xD;
&#xD;
          -  Pregnancy&#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>Christopher Loiselle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Medical Center Radiosurgery Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swedish Medical Center Radiosurgery Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.swedish.org/services/radiosurgery-center</url>
    <description>Click here for more information about the Swedish Medical Center Radiosurgery Center</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Benign Essential Tremor</keyword>
  <keyword>Tremor</keyword>
  <keyword>Neurologic Manifestations</keyword>
  <keyword>Nervous System Diseases</keyword>
  <keyword>Movement Disorders</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Essential Tremor</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/NCT02255929
org study id: IR 5585
nct id: NCT02255929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to examine effects (good and bad) of gamma knife radiosurgery
      for essential tremor. The gamma knife places a small lesion in the brain to suppress tremors.
This research is being done because although multiple studies evaluating gamma knife for
      essential tremor show good results, few studies evaluating patients prospectively have been
      done. Prior studies have looked at patient outcomes following treatment - also known as
      retrospective studies. In this study, data collection will initiate before treatment, to
      obtain consistent baseline evaluations from all study participants undergoing the gamma knife
      treatment and at specific intervals following treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Effectiveness based on Clinical Rating Scale for Tumor (CRST-Part B) questionnaires.
time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment
description: The change observed is represented by a writing and drawing score assessment of tremors. The assessment is conducted by a movement disorder neurologist in a blinded fashion.
measure: Safety Based on the Number of Incidences and Severity of Adverse Events Related with Gamma Knife Thalamotomy
time frame: Baseline, 6, 12, 24, and 36 Months Post Treatment
description: Adverse Events to be reported as mild, moderate or severe
arm group label: Gamma Knife Radiosurgery
arm group type: Experimental
description: Gamma Knife treatment is conducted in one day and takes approximately 70 to 90 minutes.
intervention type: Radiation
intervention name: Gamma Knife Radiosurgery
arm group label: Gamma Knife Radiosurgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Loiselle, MD
role: Principal Investigator
affiliation: Swedish Medical Center Radiosurgery Center
facility: 
country: United States
url: http://www.swedish.org/services/radiosurgery-center
description: Click here for more information about the Swedish Medical Center Radiosurgery Center
responsible party type: Sponsor
mesh term: Tremor
mesh term: Essential Tremor