<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/NCT01721460</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0400</org_study_id>
    <nct_id>NCT01721460</nct_id>
  </id_info>
  <brief_title>Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus</brief_title>
  <official_title>Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out whether dexmedetomidine changes brain cell&#xD;
      activity in the subthalamic nucleus (STN).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to find whether dexmedetomidine is optimal for sedation during Deep brain&#xD;
      stimulation surgery, we will measure the electrical activity in the STN during Deep brain&#xD;
      stimulation surgery, and measure how this activity is changed during administration of&#xD;
      Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and&#xD;
      pattern in the STN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>Phase 4</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 Average Population Spiking Activity</measure>
    <time_frame>20-35 minutes following drug administration</time_frame>
    <description>We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.&#xD;
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Average Firing Pattern in the STN</measure>
    <time_frame>20-35 minutes following drug administration</time_frame>
    <description>We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery</measure>
    <time_frame>20-60 minutes after stopping drug administration</time_frame>
    <description>The time it takes for the patient to become alert after drug administration is stopped.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Portion of Participants With Timely Return of the Neuronal Activity to Baseline</measure>
    <time_frame>30 minutes after stopping drug administration</time_frame>
    <description>The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Deep Brain Stimulation Surgery</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine during MER</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.</description>
    <arm_group_label>Dexmedetomidine during MER</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to undergo bilateral STN electrode implantation surgery with&#xD;
             Micro-electrode recording for the treatment of Parkinson's disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to dexmedetomidine&#xD;
&#xD;
          -  Bradycardia: Sinus rhythm slower than 50 bpm&#xD;
&#xD;
          -  Known or suspected obstructive sleep apnea&#xD;
&#xD;
          -  Suspected difficult intubation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Under 18 years of age or over 85 years of age&#xD;
&#xD;
          -  Cognitive disability impairing understanding the experiment or signing the informed&#xD;
             consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aeyal Raz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison, Department of anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin - Madison, School of Medicine and Public Health</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <results_first_submitted>June 1, 2017</results_first_submitted>
  <results_first_submitted_qc>October 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 6, 2017</results_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SubThalamic Nucleus</keyword>
  <keyword>Microelectrode recording</keyword>
  <keyword>Deep Brain Stimulation Electrode implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dexmedetomidine During MER</title>
          <description>Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.&#xD;
Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dexmedetomidine During MER</title>
          <description>Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.&#xD;
Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.5" lower_limit="53" upper_limit="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Average Population Spiking Activity</title>
        <description>We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.&#xD;
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.</description>
        <time_frame>20-35 minutes following drug administration</time_frame>
        <population>All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine Modulation of MER</title>
            <description>Change in RMS value between baseline (awake) and maximal sedation during dexmedetomidine administration.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Population Spiking Activity</title>
          <description>We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.&#xD;
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.</description>
          <population>All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.</population>
          <units>Percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.8" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Average Firing Pattern in the STN</title>
        <description>We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.</description>
        <time_frame>20-35 minutes following drug administration</time_frame>
        <population>All participants that received sedation</population>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine During MER</title>
            <description>Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.&#xD;
Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Firing Pattern in the STN</title>
          <description>We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.</description>
          <population>All participants that received sedation</population>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" spread="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery</title>
        <description>The time it takes for the patient to become alert after drug administration is stopped.</description>
        <time_frame>20-60 minutes after stopping drug administration</time_frame>
        <population>All participants that received sedation.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine During MER</title>
            <description>Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery</title>
          <description>The time it takes for the patient to become alert after drug administration is stopped.</description>
          <population>All participants that received sedation.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Portion of Participants With Timely Return of the Neuronal Activity to Baseline</title>
        <description>The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.</description>
        <time_frame>30 minutes after stopping drug administration</time_frame>
        <population>All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.</population>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine During MER</title>
            <description>Administration of dexmedetomidine during the Microelectrode recording (MER) part of subthalamic nucleus (STN) electrode implantation surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Portion of Participants With Timely Return of the Neuronal Activity to Baseline</title>
          <description>The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.</description>
          <population>All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Duration of procedure, 6-10 hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.&#xD;
Dexmedetomidine: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Aeyal Raz</name_or_title>
      <organization>University od Wisconsin - Madison</organization>
      <phone>608-263-8100</phone>
      <email>raz@wisc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01721460
org study id: 2012-0400
nct id: NCT01721460
lead sponsor: 
has dmc: Yes
The purpose of this research study is to find out whether dexmedetomidine changes brain cell
      activity in the subthalamic nucleus (STN).
In order to find whether dexmedetomidine is optimal for sedation during Deep brain
      stimulation surgery, we will measure the electrical activity in the STN during Deep brain
      stimulation surgery, and measure how this activity is changed during administration of
      Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and
      pattern in the STN.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Average Population Spiking Activity
time frame: 20-35 minutes following drug administration
description: We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
measure: Change in Average Firing Pattern in the STN
time frame: 20-35 minutes following drug administration
description: We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
measure: Time to Recovery
time frame: 20-60 minutes after stopping drug administration
description: The time it takes for the patient to become alert after drug administration is stopped.
measure: Portion of Participants With Timely Return of the Neuronal Activity to Baseline
time frame: 30 minutes after stopping drug administration
description: The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
arm group label: Dexmedetomidine during MER
arm group type: Experimental
description: The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
intervention type: Drug
intervention name: Dexmedetomidine
description: Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
arm group label: Dexmedetomidine during MER
other name: Precedex
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Aeyal Raz, MD, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison, Department of anesthesiology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dexmedetomidine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 