<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/NCT02216435</url>
  </required_header>
  <id_info>
    <org_study_id>13-2965</org_study_id>
    <secondary_id>Univeristy of Colorado</secondary_id>
    <nct_id>NCT02216435</nct_id>
  </id_info>
  <brief_title>Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata</brief_title>
  <official_title>Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata in Movement Initiation and Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,&#xD;
      slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain&#xD;
      Stimulation (DBS) is the FDA-approved method for patients who no longer get effective&#xD;
      treatment from the best available medication. The location in the brain where the electrode&#xD;
      is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims&#xD;
      to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.&#xD;
      The SNr is also known to be involved in motor control of muscles and may be involved in the&#xD;
      process by which the initiation of movement occurs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,&#xD;
      slowness of movement, slowness of initiation of movement or rigidity of muscles. One method&#xD;
      of easing PD symptoms is the FDA-approved method of Deep Brain Stimulation (DBS) for patients&#xD;
      who no longer get effective treatment from the best available medication. The location in the&#xD;
      brain where the electrode is placed during DBS surgery for PD is called the Subthalamic&#xD;
      Nucleus or STN. During placement of the DBS electrode, the patient is awake and is asked to&#xD;
      do motor tasks to determine the correct placement in the STN and proper functioning of the&#xD;
      DBS electrode. This study aims to investigate another location in the brain, the Substantia&#xD;
      nigra pars reticulata or SNr, during the normal placement of the DBS electrode. This location&#xD;
      is also known to be involved in motor control of muscles and may be involved in the process&#xD;
      by which the initiation of movement occurs. The path through the brain to the STN used for&#xD;
      DBS surgery goes into the SNr but currently, no testing of the SNr is performed. We will&#xD;
      conduct a simple and well documented visual motor test to document the patient's stimulus&#xD;
      perception and motor intention both at rest and during neural stimulation of the SNr.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 22, 2021</completion_date>
  <primary_completion_date type="Actual">February 22, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Activity of the SNr</measure>
    <time_frame>Immediately during Deep Brain Stimulation Surgery</time_frame>
    <description>Recording and evaluating brain activity from the SNr (Substantia Nigra Pars Reticulata) in Parkinson's disease patients while the patient is undergoing the visual motor testing during Deep Brain Stimulation Surgery.</description>
  </primary_outcome>
  <enrollment type="Actual">14</enrollment>
  <condition>Parkinson's Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Parkinson's disease who are candidates for Deep Brain Stimulation surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Parkinson's disease&#xD;
&#xD;
          -  must be able to undergo awake surgery DBS&#xD;
&#xD;
          -  must have unaided vision to view visual motor task&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  corrective eyeglasses or contact lenses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John A Thompson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</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/NCT02216435
org study id: 13-2965
secondary id: Univeristy of Colorado
nct id: NCT02216435
lead sponsor: 
has dmc: No
Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,
      slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain
      Stimulation (DBS) is the FDA-approved method for patients who no longer get effective
      treatment from the best available medication. The location in the brain where the electrode
      is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims
      to investigate another location in the brain, the Substantia nigra pars reticulata or SNr.
      The SNr is also known to be involved in motor control of muscles and may be involved in the
      process by which the initiation of movement occurs.
Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement,
      slowness of movement, slowness of initiation of movement or rigidity of muscles. One method
      of easing PD symptoms is the FDA-approved method of Deep Brain Stimulation (DBS) for patients
      who no longer get effective treatment from the best available medication. The location in the
      brain where the electrode is placed during DBS surgery for PD is called the Subthalamic
      Nucleus or STN. During placement of the DBS electrode, the patient is awake and is asked to
      do motor tasks to determine the correct placement in the STN and proper functioning of the
      DBS electrode. This study aims to investigate another location in the brain, the Substantia
      nigra pars reticulata or SNr, during the normal placement of the DBS electrode. This location
      is also known to be involved in motor control of muscles and may be involved in the process
      by which the initiation of movement occurs. The path through the brain to the STN used for
      DBS surgery goes into the SNr but currently, no testing of the SNr is performed. We will
      conduct a simple and well documented visual motor test to document the patient's stimulus
      perception and motor intention both at rest and during neural stimulation of the SNr.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Activity of the SNr
time frame: Immediately during Deep Brain Stimulation Surgery
description: Recording and evaluating brain activity from the SNr (Substantia Nigra Pars Reticulata) in Parkinson's disease patients while the patient is undergoing the visual motor testing during Deep Brain Stimulation Surgery.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: John A Thompson, Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease