<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/NCT02249559</url>
  </required_header>
  <id_info>
    <org_study_id>14-00902</org_study_id>
    <nct_id>NCT02249559</nct_id>
  </id_info>
  <brief_title>Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease</brief_title>
  <acronym>GKSTN</acronym>
  <official_title>Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife&#xD;
      subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain&#xD;
      stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the study is to enroll 20 subjects who could benefit from unilateral&#xD;
      subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or&#xD;
      dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates&#xD;
      for deep brain stimulation (DBS) because of advanced age (&gt;74), medical comorbidities&#xD;
      precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in&#xD;
      Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.&#xD;
&#xD;
      Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for&#xD;
      Parkinson's disease (PD), as determined by changes in the patient's clinical status and any&#xD;
      improvement following the treatment. A full neurologic exam as well as a screen for&#xD;
      depression will be administered at every postoperative visit. The patient's neurologic&#xD;
      function will be assessed with a full neurological examination and objectively quantified&#xD;
      using the UPDRS focusing on the contralateral side, as well as overall UPDRS.&#xD;
&#xD;
      The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State&#xD;
      Examination (MMSE) at each visit to record overall impression of the patient's disease&#xD;
      progression and severity, and to evaluate cognitive function. Pre- and post-treatment&#xD;
      assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen&#xD;
      in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma&#xD;
      knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease&#xD;
      Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be&#xD;
      filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at&#xD;
      each clinic visit to monitor for development or progression of depressive symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients</measure>
    <time_frame>12 months</time_frame>
    <description>Safety of GK subthalamotomy in the management of PD as measured by stable findings on neurologic exam at each clinic visit (hemiballismus, dyskinesias, sensory changes) and the absence of Serious Adverse Events (SAE) attributable to treatment.&#xD;
Because this study does not have a control group, we will compare the non-inferiority of GK subthalamotomy to published outcomes in PD patients undergoing other forms of management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of GK subthalamotomy for PD</measure>
    <time_frame>12 months</time_frame>
    <description>To be determined by changes in the patient's clinical status and any improvement following the treatment.&#xD;
Neurologic function as determined by UPDRS, MMSE, neurologic exam results, CGI assessment and LEDD score.&#xD;
Quality of life, as determined by PDQ-39 score and Beck's Depression Inventory (BDI) score.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Parkinsons Disease</condition>
  <arm_group>
    <arm_group_label>GK subthalamotomy</arm_group_label>
    <description>Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise appropriate DBS candidates but deemed suboptimal for DBS on account of one&#xD;
             or more of the following:&#xD;
&#xD;
               -  advanced age greater than 74 years of age&#xD;
&#xD;
               -  medical comorbidities&#xD;
&#xD;
                    -  need for continual anticoagulation&#xD;
&#xD;
                    -  poor candidates for general anesthesia based on cardiac, hepatic ,renal or&#xD;
                       pulmonary status&#xD;
&#xD;
                    -  high infection risk if internal DBS device hardware is placed (ie. Poor&#xD;
                       diabetes mellitus control)&#xD;
&#xD;
               -  patient aversion to DBS&#xD;
&#xD;
          2. Patients with asymmetric disease symptoms including:&#xD;
&#xD;
               -  rigidity&#xD;
&#xD;
               -  tremor&#xD;
&#xD;
               -  bradykinesia&#xD;
&#xD;
               -  dyskinesia&#xD;
&#xD;
          3. More than 30% improvement in UPDRS score in ON versus OFF medication state, except:&#xD;
&#xD;
               -  in the presence of disabling contralateral dyskinesias/dystonia limiting dose&#xD;
                  tolerance&#xD;
&#xD;
               -  tremors that are medically refractory&#xD;
&#xD;
          4. Patients who are on a stable medication regimen and demonstrating stable disease&#xD;
             symptoms (absence of significant improvement or deterioration) for at least 3 months&#xD;
             at the time of GKS, as determined by review of medical record&#xD;
&#xD;
          5. MMSE score greater than or equal to 26&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prominent axial symptoms including postural instability and gait&#xD;
             disturbances, defined as a score of 3 or greater on Questions 28, 29 &amp; 30 on the UPDRS&#xD;
&#xD;
          -  Patients whose symptoms do not improve by more than 30% in UPDRS score with&#xD;
             medication, unless patient experiences dose-limiting side effects&#xD;
&#xD;
          -  The presence of dementia or inability to provide informed consent for participation in&#xD;
             the study, as determined by a mini-mental status examination score below 25&#xD;
&#xD;
          -  Patients who have had prior brain radiation&#xD;
&#xD;
          -  Patients with improvement and satisfactory symptom management will not be offered this&#xD;
             procedure. We will only include patients without satisfactory symptom management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>74 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Douglas Kondziolka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU MEDICAL CENTER</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>December 4, 2017</last_update_submitted>
  <last_update_submitted_qc>December 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</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>Parkinson Disease</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/NCT02249559
org study id: 14-00902
nct id: NCT02249559
lead sponsor: 
has dmc: Yes
This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife
      subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain
      stimulation.
The goal of the study is to enroll 20 subjects who could benefit from unilateral
      subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or
      dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates
      for deep brain stimulation (DBS) because of advanced age (>74), medical comorbidities
      precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in
      Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.

      Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for
      Parkinson's disease (PD), as determined by changes in the patient's clinical status and any
      improvement following the treatment. A full neurologic exam as well as a screen for
      depression will be administered at every postoperative visit. The patient's neurologic
      function will be assessed with a full neurological examination and objectively quantified
      using the UPDRS focusing on the contralateral side, as well as overall UPDRS.

      The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State
      Examination (MMSE) at each visit to record overall impression of the patient's disease
      progression and severity, and to evaluate cognitive function. Pre- and post-treatment
      assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen
      in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma
      knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease
      Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be
      filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at
      each clinic visit to monitor for development or progression of depressive symptoms.
observational model: Case-Only
time perspective: Prospective
measure: Safety of performing GK lesions in the Subthalamic Nucleus (STN) for PD patients
time frame: 12 months
description: Safety of GK subthalamotomy in the management of PD as measured by stable findings on neurologic exam at each clinic visit (hemiballismus, dyskinesias, sensory changes) and the absence of Serious Adverse Events (SAE) attributable to treatment.
Because this study does not have a control group, we will compare the non-inferiority of GK subthalamotomy to published outcomes in PD patients undergoing other forms of management.
measure: Efficacy of GK subthalamotomy for PD
time frame: 12 months
description: To be determined by changes in the patient's clinical status and any improvement following the treatment.
Neurologic function as determined by UPDRS, MMSE, neurologic exam results, CGI assessment and LEDD score.
Quality of life, as determined by PDQ-39 score and Beck's Depression Inventory (BDI) score.
arm group label: GK subthalamotomy
description: Evaluate the safety and efficacy of unilateral GK subthalamotomy for PD in patients deemed poor candidates for DBS.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 74 Years
maximum age: N/A
healthy volunteers: No
last name: Douglas Kondziolka, MD
role: Principal Investigator
affiliation: NYU MEDICAL CENTER
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease