<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/NCT02982512</url>
  </required_header>
  <id_info>
    <org_study_id>DEXPAR</org_study_id>
    <nct_id>NCT02982512</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's Disease</brief_title>
  <official_title>Effects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The implantation of a deep brain stimulator (DBS) is an established option to improve the&#xD;
      symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical&#xD;
      therapy. Most centers perform this surgery using a technique that involves microelectrode&#xD;
      recording (MER) of neuronal activity for localization of the target nucleus, microstimulation&#xD;
      of identified targets, and neurological intraoperative testing in a cooperative patient.&#xD;
&#xD;
      Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at&#xD;
      subcortical areas of the brain without involving GABA receptors. It provides excellent&#xD;
      sedation without respiratory depression; also, it has an analgesic component and a&#xD;
      predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.&#xD;
      The possible effect of dexmedetomidine in the PD symptoms is still unclear.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The implantation of a deep brain stimulator (DBS) is an established option to improve the&#xD;
      symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical&#xD;
      therapy. Most centers perform this surgery using a technique that involves microelectrode&#xD;
      recording (MER) of neuronal activity for localization of the target nucleus, microstimulation&#xD;
      of identified targets, and neurological intraoperative testing in a cooperative patient. This&#xD;
      surgery is usually performed in two stages. In the first stage, and under conscious sedation&#xD;
      (CS), the target nucleus is localized and the DBS is implanted. About 5 days later, and under&#xD;
      general anaesthesia, a programmable pulse generator is implanted and connected to the DBS.&#xD;
&#xD;
      The anesthetic approach varies depending on the institution, ranging from local anesthesia&#xD;
      only with monitored care, conscious sedation, and the &quot;asleep-awake&quot; or &quot;asleep-awake-asleep&quot;&#xD;
      technique. But sedative drugs can affect the quality of MER by suppressing the firing rate of&#xD;
      basal ganglia structures, and alter PD symptoms. Propofol is the drug most commonly used. Its&#xD;
      real influence on the quality of MER and PD symptoms is still today controversial. In recent&#xD;
      years, some studies have suggested using dexmedetomidine as the main sedative agent for this&#xD;
      intervention. Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that&#xD;
      acts at subcortical areas of the brain without involving GABA receptors. It provides&#xD;
      excellent sedation without respiratory depression; also, it has an analgesic component and a&#xD;
      predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.&#xD;
      The possible effect of dexmedetomidine in the PD symptoms is still unclear. All these&#xD;
      characteristics make it a good choice for sedation of PD patients undergoing DBS surgery.&#xD;
&#xD;
      Studying the influence of anesthetic drugs on basal ganglia activity and PD motor symptoms in&#xD;
      humans and in a clinical setting is complicated. First, it is difficult to establish a&#xD;
      control group to compare effects in different nuclei. There is some data concerning clinical&#xD;
      outcomes (clinical symptoms or long term stimulation parameters) but without&#xD;
      electrophysiological data. MERs data has been compared between different patients or in the&#xD;
      same patient but between contralateral targets. Few studies analyze electrophysiological data&#xD;
      with or without one sedative drug in the same target.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beta activity (15-35 Hz)</measure>
    <time_frame>Control and dexmedetomidine exposure (around 300 min of continuous recording)</time_frame>
    <description>Global power in the beta band (15-35 Hz) of the electrical oscillatory activity from deep brain structures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bispectral index scales (a single dimensionless number ranges from 0 - 100)</measure>
    <time_frame>Control and dexmedetomidine exposure (around 300 min of continuous recording)</time_frame>
    <description>Weighted sum of several electroencephalographic subparameters, including a time domain, frequency domain, and high order spectral subparameters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Dexmedetomidine</condition>
  <condition>Deep Brain Stimulation</condition>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Control recording</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Recording of local field potentials without drugs from the deep brain stimulator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomodine recording</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Administration of dexmedetomidine a different concetrations</description>
    <arm_group_label>Dexmedetomodine recording</arm_group_label>
    <other_name>Dexdor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing placement of DBS for PD in two phases.&#xD;
&#xD;
          -  The patient must be of legal age (&gt; 17 years old).&#xD;
&#xD;
          -  The patient or his representative has consented to participate in the study.&#xD;
&#xD;
          -  The patient should, in the investigator's opinion, be able to cooperate during the&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known liver disease.&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
&#xD;
          -  History of hypersensitivity to dexmedetomidine.&#xD;
&#xD;
          -  Heart block (2nd or 3rd degree), without pacemaker.&#xD;
&#xD;
          -  Symptomatic hypotension.&#xD;
&#xD;
          -  Severe stroke or other neurological deficits that may impair adequate cooperation or&#xD;
             observation of the study endpoints.&#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>Martinez-Simon Antonio, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Staff of Anesthesiology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martinez-Simon Antonio, MD, PhD</last_name>
    <phone>+34 948255400</phone>
    <phone_ext>4813</phone_ext>
    <email>amartinezs@unav.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernandez Javier</last_name>
    <phone>+34 948255400</phone>
    <phone_ext>2723</phone_ext>
    <email>jjfernandez@unav.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clínica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernandez J Javier</last_name>
      <phone>948255400</phone>
      <phone_ext>4717</phone_ext>
      <email>jjfernanderz@unav.es</email>
    </contact>
    <contact_backup>
      <last_name>Martinez-Simon Antonio, MD, PhD</last_name>
      <phone>948255400</phone>
      <phone_ext>4813</phone_ext>
      <email>amartinezs@unav.es</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Potential local fields</keyword>
  <keyword>Subthalamic neuronal activity</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>
  <!-- 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/NCT02982512
org study id: DEXPAR
nct id: NCT02982512
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The implantation of a deep brain stimulator (DBS) is an established option to improve the
      symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical
      therapy. Most centers perform this surgery using a technique that involves microelectrode
      recording (MER) of neuronal activity for localization of the target nucleus, microstimulation
      of identified targets, and neurological intraoperative testing in a cooperative patient.

      Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that acts at
      subcortical areas of the brain without involving GABA receptors. It provides excellent
      sedation without respiratory depression; also, it has an analgesic component and a
      predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.
      The possible effect of dexmedetomidine in the PD symptoms is still unclear.
The implantation of a deep brain stimulator (DBS) is an established option to improve the
      symptoms of Parkinson's disease (PD) in patients that do not respond adequately to medical
      therapy. Most centers perform this surgery using a technique that involves microelectrode
      recording (MER) of neuronal activity for localization of the target nucleus, microstimulation
      of identified targets, and neurological intraoperative testing in a cooperative patient. This
      surgery is usually performed in two stages. In the first stage, and under conscious sedation
      (CS), the target nucleus is localized and the DBS is implanted. About 5 days later, and under
      general anaesthesia, a programmable pulse generator is implanted and connected to the DBS.

      The anesthetic approach varies depending on the institution, ranging from local anesthesia
      only with monitored care, conscious sedation, and the "asleep-awake" or "asleep-awake-asleep"
      technique. But sedative drugs can affect the quality of MER by suppressing the firing rate of
      basal ganglia structures, and alter PD symptoms. Propofol is the drug most commonly used. Its
      real influence on the quality of MER and PD symptoms is still today controversial. In recent
      years, some studies have suggested using dexmedetomidine as the main sedative agent for this
      intervention. Dexmedetomidine, a α2-adrenergic receptors agonist, is a potent anxiolytic that
      acts at subcortical areas of the brain without involving GABA receptors. It provides
      excellent sedation without respiratory depression; also, it has an analgesic component and a
      predictable hemodynamic response. Low maintenance doses do not appear to interfere with MER.
      The possible effect of dexmedetomidine in the PD symptoms is still unclear. All these
      characteristics make it a good choice for sedation of PD patients undergoing DBS surgery.

      Studying the influence of anesthetic drugs on basal ganglia activity and PD motor symptoms in
      humans and in a clinical setting is complicated. First, it is difficult to establish a
      control group to compare effects in different nuclei. There is some data concerning clinical
      outcomes (clinical symptoms or long term stimulation parameters) but without
      electrophysiological data. MERs data has been compared between different patients or in the
      same patient but between contralateral targets. Few studies analyze electrophysiological data
      with or without one sedative drug in the same target.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Beta activity (15-35 Hz)
time frame: Control and dexmedetomidine exposure (around 300 min of continuous recording)
description: Global power in the beta band (15-35 Hz) of the electrical oscillatory activity from deep brain structures.
measure: Bispectral index scales (a single dimensionless number ranges from 0 - 100)
time frame: Control and dexmedetomidine exposure (around 300 min of continuous recording)
description: Weighted sum of several electroencephalographic subparameters, including a time domain, frequency domain, and high order spectral subparameters
arm group label: Control recording
arm group type: No Intervention
description: Recording of local field potentials without drugs from the deep brain stimulator
arm group label: Dexmedetomodine recording
arm group type: Experimental
description: Recording of local field potentials at different dexmedetomidine concentrations from the deep brain stimulator
intervention type: Drug
intervention name: Dexmedetomidine
description: Administration of dexmedetomidine a different concetrations
arm group label: Dexmedetomodine recording
other name: Dexdor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martinez-Simon Antonio, MD, PhD
role: Principal Investigator
affiliation: Staff of Anesthesiology Department
last name: Martinez-Simon Antonio, MD, PhD
phone: +34 948255400
phone ext: 4813
email: amartinezs@unav.es
last name: Fernandez Javier
phone: +34 948255400
phone ext: 2723
email: jjfernandez@unav.es
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Dexmedetomidine