<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/NCT01705301</url>
  </required_header>
  <id_info>
    <org_study_id>09-007441</org_study_id>
    <nct_id>NCT01705301</nct_id>
  </id_info>
  <brief_title>Neurotransmitter Measurements Using (WINCS) During Deep Brain Stimulation Neurosurgery</brief_title>
  <official_title>Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators will monitor extracellular neurotransmitter levels using a&#xD;
      probe that is able to perform real time electrochemical detection during deep brain&#xD;
      stimulation surgery. The overall question this study is designed to answer is: Are there&#xD;
      neurotransmitters released during deep brain stimulation?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, the investigators will monitor extracellular neurotransmitter levels using a&#xD;
      probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The&#xD;
      overall question this study is designed to answer is: Are there neurotransmitters released&#xD;
      during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the&#xD;
      three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are&#xD;
      undergoing DBS neurosurgery. This will be an acute study. Patients with medically&#xD;
      identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for&#xD;
      implantation of DBS will be selected for this study. These patients will then be consented&#xD;
      preoperatively to undergo extracellular electrophysiology which is typical in these cases to&#xD;
      determine the target site for implantation of the DBS electrodes. Following this&#xD;
      electrophysiologic procedure, the patient will have electrochemical electrode implanted to&#xD;
      (1) determine whether there is adenosine release at the site of stimulation during ventral&#xD;
      intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and&#xD;
      adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and&#xD;
      (3) determine whether there is dopamine and adenosine release at the site of stimulation&#xD;
      during Globus Pallidus DBS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">July 27, 2017</completion_date>
  <primary_completion_date type="Actual">July 27, 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>adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device</measure>
    <time_frame>30 minutes</time_frame>
    <description>Pre, during, post DBS (deep brain stimulation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device</measure>
    <time_frame>30 minutes</time_frame>
    <description>Pre, during, post DBS (deep brain stimulation)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Essential Tremor</condition>
  <condition>Parkinson's Disease</condition>
  <condition>Dystonia</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <description>Patient's undergoing the clinical procedure of Deep Brain Stimulation will have the experimental protocol that involves, after implantation of the DBS electrodes, a single electrochemical recording electrode, from the WINCS system, implanted along the same trajectory path as the electrophysiology and the DBS electrode</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WINCS</intervention_name>
    <description>The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode</description>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and&#xD;
        Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS&#xD;
        committee.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult Patients with medically intractable Essential Tremor, Parkinson's Disease, and&#xD;
             Dystonia who have been approved for DBS surgery by the interdisciplinary Mayo DBS&#xD;
             committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant patients,&#xD;
&#xD;
          -  prisoners,&#xD;
&#xD;
          -  children (age less than 18), and&#xD;
&#xD;
          -  any patients identified as unsuitable for these protocol by the Mayo DBS committee.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kendall Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kendall H. Lee</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Dystonia</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/NCT01705301
org study id: 09-007441
nct id: NCT01705301
lead sponsor: 
has dmc: No
In this study, the investigators will monitor extracellular neurotransmitter levels using a
      probe that is able to perform real time electrochemical detection during deep brain
      stimulation surgery. The overall question this study is designed to answer is: Are there
      neurotransmitters released during deep brain stimulation?
In this study, the investigators will monitor extracellular neurotransmitter levels using a
      probe that is able to perform realtime electrochemical detection during DBS neurosurgery. The
      overall question this study is designed to answer is: Are there neurotransmitters released
      during deep brain stimulation? We propose to enroll 45 patients (15 patients each at the
      three targets for DBS) with Essential Tremor, Parkinson's Disease, and Dystonia who are
      undergoing DBS neurosurgery. This will be an acute study. Patients with medically
      identifiable symptoms of the above diseases who have been approved by Mayo DBS committee for
      implantation of DBS will be selected for this study. These patients will then be consented
      preoperatively to undergo extracellular electrophysiology which is typical in these cases to
      determine the target site for implantation of the DBS electrodes. Following this
      electrophysiologic procedure, the patient will have electrochemical electrode implanted to
      (1) determine whether there is adenosine release at the site of stimulation during ventral
      intermediate nucleus (VIM) thalamic DBS, (2) determine whether there is dopamine and
      adenosine release within the caudate nucleus or putamen during subthalamic nucleus DBS, and
      (3) determine whether there is dopamine and adenosine release at the site of stimulation
      during Globus Pallidus DBS.
observational model: Cohort
time perspective: Prospective
measure: adenosine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
time frame: 30 minutes
description: Pre, during, post DBS (deep brain stimulation)
measure: dopamine release in brain as measured by WINCS (Wireless Instantaneous Neurochemical Concentration Sensing System)recording device
time frame: 30 minutes
description: Pre, during, post DBS (deep brain stimulation)
arm group label: Deep Brain Stimulation
description: Patient's undergoing the clinical procedure of Deep Brain Stimulation will have the experimental protocol that involves, after implantation of the DBS electrodes, a single electrochemical recording electrode, from the WINCS system, implanted along the same trajectory path as the electrophysiology and the DBS electrode
intervention type: Device
intervention name: WINCS
description: The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode
arm group label: Deep Brain Stimulation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Kendall Lee, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kendall H. Lee
investigator title: PI
mesh term: Parkinson Disease
mesh term: Dystonia
mesh term: Essential Tremor